Trial Outcomes & Findings for Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth (NCT NCT02379728)

Last Updated: 2020-04-02

Results Overview

Birthweight was measured using a Detecto newborn scale (Webb City, USA) and documented in the participant's hospital folder immediately after delivery by a midwife who was not a part of the study team and was not aware of the treatment allocation. Birthweight was subsequently abstracted by the blinded outcomes assessor. Analysis was by original assigned groups and on a complete-case basis (drop-outs excluded). The newborns included in the final analysis were born from November 31, 2015 through May 13, 2016.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

At delivery of baby (on average, 38 - 40 weeks gestation)

Results posted on

2020-04-02

Participant Flow

Participants were recruited by maternity personnel when presenting for antenatal care at the Korle Bu Teaching Hospital. Between September 2015 and March 2016, 276 women were assessed for eligibility. Seventy-six (28%) did not meet the eligibility criteria. When the target enrollment (N=200) was reached, recruitment was stopped.

Participant milestones

Participant milestones
Measure	PrenaBelt Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	PrenaBelt With Body Position Sensor Participants will be instructed to use the PrenaBelt (with integrated body position sensor (BPS)) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery. sham-PrenaBelt: The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.	Control With Body Position Sensor (BPS) Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Overall Study STARTED	84	16	84	16
Overall Study COMPLETED	78	16	74	13
Overall Study NOT COMPLETED	6	0	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	PrenaBelt Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. Participants will be followed by study personnel through the remainder of pregnancy and delivery. sham-PrenaBelt: The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.	Control With Body Position Sensor (BPS) Participants will be instructed to use the sham-PrenaBelt (with integrated BPS) nightly for the remainder of their pregnancy in addition to receiving the local standard of care. The BPS will be securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Overall Study Lost to Follow-up	1	3	0
Overall Study Withdrawal by Subject	5	5	3
Overall Study Protocol Violation	0	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Total n=162 Participants Total of all reporting groups
Age, Continuous	29 years n=82 Participants	29 years n=80 Participants	29 years n=162 Participants
Sex: Female, Male Female	82 Participants n=82 Participants	80 Participants n=80 Participants	162 Participants n=162 Participants
Sex: Female, Male Male	0 Participants n=82 Participants	0 Participants n=80 Participants	0 Participants n=162 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Ghana	82 participants n=82 Participants	80 participants n=80 Participants	162 participants n=162 Participants
Gestational age (weeks)	28 weeks n=82 Participants	28 weeks n=80 Participants	28 weeks n=162 Participants
Gravidity Gravida 1	20 Participants n=82 Participants	31 Participants n=80 Participants	51 Participants n=162 Participants
Gravidity Gravida ≥2	62 Participants n=82 Participants	49 Participants n=80 Participants	111 Participants n=162 Participants
Parity Para 0	29 Participants n=82 Participants	38 Participants n=80 Participants	67 Participants n=162 Participants
Parity Para ≥1	53 Participants n=82 Participants	42 Participants n=80 Participants	95 Participants n=162 Participants
Education Tertiary	50 Participants n=82 Participants	48 Participants n=80 Participants	98 Participants n=162 Participants
Education Vocational	1 Participants n=82 Participants	1 Participants n=80 Participants	2 Participants n=162 Participants
Education Senior High	15 Participants n=82 Participants	26 Participants n=80 Participants	41 Participants n=162 Participants
Education Junior High or less	16 Participants n=82 Participants	5 Participants n=80 Participants	21 Participants n=162 Participants
Household Income	1200 Cedis per month n=75 Participants • Some participants did not wish to disclose this information.	1500 Cedis per month n=77 Participants • Some participants did not wish to disclose this information.	1350 Cedis per month n=152 Participants • Some participants did not wish to disclose this information.
Current BMI	28.9 kg/m^2 STANDARD_DEVIATION 4.2 • n=80 Participants • Some participants did not wish to disclose this information.	28.9 kg/m^2 STANDARD_DEVIATION 4.3 • n=78 Participants • Some participants did not wish to disclose this information.	28.9 kg/m^2 STANDARD_DEVIATION 4.3 • n=158 Participants • Some participants did not wish to disclose this information.
Pre-pregnancy BMI	26.1 kg/m^2 STANDARD_DEVIATION 4.2 • n=80 Participants • Some participants did not wish to disclose this information.	26.2 kg/m^2 STANDARD_DEVIATION 4.1 • n=77 Participants • Some participants did not wish to disclose this information.	26.2 kg/m^2 STANDARD_DEVIATION 4.1 • n=157 Participants • Some participants did not wish to disclose this information.
Nightly sleep duration	7.8 Hours STANDARD_DEVIATION 1.3 • n=81 Participants • One participant did not wish to disclose this information.	8.2 Hours STANDARD_DEVIATION 1.3 • n=80 Participants • One participant did not wish to disclose this information.	8.0 Hours STANDARD_DEVIATION 1.3 • n=161 Participants • One participant did not wish to disclose this information.
In the last week, sleep onset position Left	41 Participants n=82 Participants	46 Participants n=80 Participants	87 Participants n=162 Participants
In the last week, sleep onset position Supine	12 Participants n=82 Participants	8 Participants n=80 Participants	20 Participants n=162 Participants
In the last week, sleep onset position Right	33 Participants n=82 Participants	29 Participants n=80 Participants	62 Participants n=162 Participants
In the last week, sleep onset position Prone	2 Participants n=82 Participants	0 Participants n=80 Participants	2 Participants n=162 Participants
In the last week, waking position Left	30 Participants n=82 Participants	32 Participants n=80 Participants	62 Participants n=162 Participants
In the last week, waking position Supine	22 Participants n=82 Participants	18 Participants n=80 Participants	40 Participants n=162 Participants
In the last week, waking position Right	26 Participants n=82 Participants	31 Participants n=80 Participants	57 Participants n=162 Participants
In the last week, waking position Prone	4 Participants n=82 Participants	2 Participants n=80 Participants	6 Participants n=162 Participants
When not pregnant, sleep onset positions Left	6 Participants n=82 Participants	7 Participants n=80 Participants	13 Participants n=162 Participants
When not pregnant, sleep onset positions Supine	25 Participants n=82 Participants	26 Participants n=80 Participants	51 Participants n=162 Participants
When not pregnant, sleep onset positions Right	10 Participants n=82 Participants	9 Participants n=80 Participants	19 Participants n=162 Participants
When not pregnant, sleep onset positions Prone	42 Participants n=82 Participants	39 Participants n=80 Participants	81 Participants n=162 Participants
When not pregnant, waking positions Left	12 Participants n=82 Participants	10 Participants n=80 Participants	22 Participants n=162 Participants
When not pregnant, waking positions Supine	25 Participants n=82 Participants	29 Participants n=80 Participants	54 Participants n=162 Participants
When not pregnant, waking positions Right	15 Participants n=82 Participants	14 Participants n=80 Participants	29 Participants n=162 Participants
When not pregnant, waking positions Prone	32 Participants n=82 Participants	27 Participants n=80 Participants	59 Participants n=162 Participants
Part of bed sleeps on Left	42 Participants n=82 Participants	31 Participants n=80 Participants	73 Participants n=162 Participants
Part of bed sleeps on Right	30 Participants n=82 Participants	35 Participants n=80 Participants	65 Participants n=162 Participants
Part of bed sleeps on Center	11 Participants n=82 Participants	12 Participants n=80 Participants	23 Participants n=162 Participants
Pillow use None	3 Participants n=82 Participants	6 Participants n=80 Participants	9 Participants n=162 Participants
Pillow use Under head	74 Participants n=82 Participants	71 Participants n=80 Participants	145 Participants n=162 Participants
Pillow use Between knees	7 Participants n=82 Participants	5 Participants n=80 Participants	12 Participants n=162 Participants
Pillow use Under tummy	4 Participants n=82 Participants	0 Participants n=80 Participants	4 Participants n=162 Participants
Pillow use Behind back	4 Participants n=82 Participants	4 Participants n=80 Participants	8 Participants n=162 Participants
Pillow use Pregnancy pillow	1 Participants n=82 Participants	0 Participants n=80 Participants	1 Participants n=162 Participants
Pillow use Other (under feet or legs)	2 Participants n=82 Participants	6 Participants n=80 Participants	8 Participants n=162 Participants
Sleeps with bed partner	65 Participants n=82 Participants • Some participants did not wish to disclose this information.	61 Participants n=78 Participants • Some participants did not wish to disclose this information.	126 Participants n=160 Participants • Some participants did not wish to disclose this information.
Uses insecticide treated bed net	19 Participants n=81 Participants • Some participants did not wish to disclose this information.	17 Participants n=78 Participants • Some participants did not wish to disclose this information.	36 Participants n=159 Participants • Some participants did not wish to disclose this information.
Snores ≥3 nights per week	9 Participants n=81 Participants • Some participants did not wish to disclose this information.	7 Participants n=77 Participants • Some participants did not wish to disclose this information.	16 Participants n=158 Participants • Some participants did not wish to disclose this information.
Past medical complications	4 Participants n=82 Participants	2 Participants n=80 Participants	6 Participants n=162 Participants

PRIMARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Population: 12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Birthweight of Baby	3186 grams Standard Deviation 484	3079 grams Standard Deviation 493

PRIMARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Birthweight centile was calculated using the Gestation-Related Optimal Weight (GROW) software,(1,2) which accounts for the main non-pathological factors affecting birthweight (gestational age, maternal height, maternal weight at booking, parity, ethnicity, and sex of the neonate) and, as such, enables delineation between constitutional and pathological smallness and more accurate detection of pregnancies at increased risk for adverse outcomes.(3,4) This was an additional trial outcome specified after trial commencement. 1. Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net 2. Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7. 3. Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8. 4. Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Birthweight Centile	43 percent Interval 18.0 to 64.0	32 percent Interval 14.0 to 60.0

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Gestational Age at Delivery	39.1 Weeks Interval 38.0 to 40.0	39.0 Weeks Interval 38.1 to 40.3

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Mode of delivery (unassisted, episiotomy, amniotomy, induced, fetal monitoring, forceps delivery, vacuum extraction, Cesarean section) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Mode of Delivery Spontaneous vaginal	50 Participants	38 Participants
Mode of Delivery Caesarean section	32 Participants	40 Participants
Mode of Delivery Vacuum extraction	0 Participants	2 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Sex of the newborn will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Sex of Newborn (Male/Female) Male	50 Participants	39 Participants
Sex of Newborn (Male/Female) Female	32 Participants	41 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

If a stillbirth occurs, it will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Stillbirth	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Low birthweight is defined as a birthweight ≤ 2500 grams at birth.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Low Birthweight	7 Participants	6 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Small for gestational age is defined as a Gestation-Related Optimal Weight (GROW) birthweight centile ≤ 10%.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Small for Gestational Age	12 Participants	18 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Preterm delivery was defined as a gestational age (in weeks) at birth of less than 37 weeks, 0 days.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Preterm Delivery	5 Participants	8 Participants

SECONDARY outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Any relevant diagnosis/diagnoses made during labor/delivery (e.g., gestational diabetes, gestational hypertension, meconium aspiration) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.

Outcome measures

Outcome measures
Measure	PrenaBelt n=82 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=80 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery	31 Participants	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: Three, of four, maternity personnel conducting the device introduction sessions answered this question on the maternity personnel questionnaire.

How long it took (in minutes), on average, to complete the Introduction and Instruction for PrenaBelt session.

Outcome measures

Outcome measures
Measure	PrenaBelt n=3 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Session Time Requirement	10 minutes Interval 5.0 to 25.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

How the medical staff person delivered the Introduction and Instruction for PrenaBelt session (e.g., one-on-one, in a group setting, or both) and the staff person's preference for delivery.

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Session Delivery One-on-one	1 Participants	—
Medical Staff Questionnaire - Session Delivery Group	0 Participants	—
Medical Staff Questionnaire - Session Delivery Both	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

Did the medical staff person or the participants encounter any difficulties during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe)

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Session Difficulties Yes	1 Participants	—
Medical Staff Questionnaire - Session Difficulties No	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

Were any cultural issues encountered during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe).

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Session Cultural Issues Yes	0 Participants	—
Medical Staff Questionnaire - Session Cultural Issues No	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

The professional training level (e.g., nursing, midwifery) of the medical staff person.

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Professional Training Level Nurse with diploma in public health	1 Participants	—
Medical Staff Questionnaire - Professional Training Level Nurse with diploma in midwifery	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

The professional experience (years working as a professional) of the medical staff person.

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Professional Experience	8.33 years Interval 4.0 to 29.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)

Population: Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.

In comparison to the medical staff person's training and experience, the difficulty rating of delivering the sessions on a scale from 1 to 10: 1 = Easy - medical staff person could have completed the sessions without training and experience. 5 = Medium difficulty - medical staff person needed to use some professional training and experience. 10 = Very difficult - professional training and experience did not help medical staff person at all

Outcome measures

Outcome measures
Measure	PrenaBelt n=4 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Medical Staff Questionnaire - Professional Difficulty Rating	4 units on a scale Interval 1.0 to 5.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Population: Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.

When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to understand the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not understand it.

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Understanding Easy	51 Participants	—
PrenaBelt User Feedback Questionnaire - Understanding Medium	1 Participants	—
PrenaBelt User Feedback Questionnaire - Understanding Difficult	0 Participants	—
PrenaBelt User Feedback Questionnaire - Understanding No response	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to learn how to use the PrenaBelt? Check box categories: Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not put the PrenaBelt on correctly.

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Learning Easy	51 Participants	—
PrenaBelt User Feedback Questionnaire - Learning Medium	1 Participants	—
PrenaBelt User Feedback Questionnaire - Learning Difficult	0 Participants	—
PrenaBelt User Feedback Questionnaire - Learning No response	3 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Did the participant use the PrenaBelt regularly (almost every night)? Check box categories: Regularly throughout her entire third trimester. More regularly at the beginning and less at the end. Less regularly at the beginning and more at the end. Not regularly at any time.

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - General Adherence Pattern Regularly throughout her entire third trimester	11 Participants	—
PrenaBelt User Feedback Questionnaire - General Adherence Pattern More regularly at the beginning, less at the end	32 Participants	—
PrenaBelt User Feedback Questionnaire - General Adherence Pattern Less regularly at the beginning, more at the end	3 Participants	—
PrenaBelt User Feedback Questionnaire - General Adherence Pattern Not regularly at any time	5 Participants	—
PrenaBelt User Feedback Questionnaire - General Adherence Pattern No response	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

When the participant was using the PrenaBelt, did she use it: Check box categories: Every night of the week. 6 nights per week. 7 nights per week. 5 nights per week. 4 nights per week. 3 nights per week. 2 nights per week. 1 nights per week. Did not use it at all.

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week Every night of the week.	10 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 6 nights per week.	1 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 5 nights per week.	25 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 4 nights per week.	5 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 3 nights per week.	7 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 2 nights per week.	2 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week 1 nights per week.	1 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week Did not use at all.	0 Participants	—
PrenaBelt User Feedback Questionnaire - Nights of Use Per Week No response.	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Did anyone tell the participant to stop using the PrenaBelt or that she should not be using the PrenaBelt (yes/no; if yes, explain)

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Deterrents to Use Yes	3 Participants	—
PrenaBelt User Feedback Questionnaire - Deterrents to Use No	52 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

Did the participant or anyone else use the PrenaBelt for anything else during daily activities besides sleep (yes/no; if yes, explain).

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Other Uses Yes	0 Participants	—
PrenaBelt User Feedback Questionnaire - Other Uses No	55 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

How does the participant think the PrenaBelt affected her sleep position. Check box categories: Participant didn't notice any difference in her sleep position Participant changed position more often. Participant spent more time sleeping on her left side. Participant woke up more often during the night when she was on her back, would roll back onto her left side, and fall asleep. Over time, participant learned to not sleep on her back and woke up less at night. In the mornings, participant always woke up on her left side. Other, please specify:

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Didn't notice a difference	2 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Changed position more often	15 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Spent more time sleeping on left	26 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Woke up on back, turned to left, fell asleep	21 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Learned not to sleep on back, woke up less often	22 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position In morning, always woke up on her left	17 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position Other	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

In general, did the participant notice anything else that was different about her sleep when using the PrenaBelt. Check box categories: Participant's sleep quality improved. Participant's sleep quality worsened. Participant's sleep duration became longer. Participant's sleep duration became shorter. During the day, participant felt more alert. During the day, participant felt more drowsy. Participant stopped snoring. Participant started snoring. Participant woke up less often throughout the night. Other, please specify:

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Started snoring	0 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Sleep quality improved	32 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Sleep quality worsened	2 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Sleep duration became longer	6 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Sleep duration became shorter	21 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep During the day, participant felt more alert	8 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep During the day, participant felt more drowsy	1 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Stopped snoring	2 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Woke up less often throughout the night	11 Participants	—
PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Other	4 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note: 1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Satisfaction	8 units on a scale Interval 6.0 to 8.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note: 1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Comfort	8 units on a scale Interval 6.0 to 9.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At delivery of baby (on average, 38 - 40 weeks gestation)

On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her. Note: 1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again

Outcome measures

Outcome measures
Measure	PrenaBelt n=55 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
PrenaBelt User Feedback Questionnaire - Intention for Future Use	8 units on a scale Interval 7.0 to 9.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Population: 143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.

Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt ("device") every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated.

Outcome measures

Outcome measures
Measure	PrenaBelt n=68 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=75 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Sleep Diary - PrenaBelt Adherence	52 % (#nights used/#nights in trial) Standard Deviation 25	56 % (#nights used/#nights in trial) Standard Deviation 26

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Outcome measures

Outcome measures
Measure	PrenaBelt n=68 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=75 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Sleep Diary - Number of Nights in Trial	80 Number of nights in trial Standard Deviation 14	76 Number of nights in trial Standard Deviation 16

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Outcome measures

Outcome measures
Measure	PrenaBelt n=68 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=75 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Sleep Diary - Number of Nights Used Device	42 Number of nights used device Standard Deviation 21	43 Number of nights used device Standard Deviation 22

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.

Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the "PrenaBelt with BPS" and "Control with BPS" Arms when she returns the BPS to study personnel after the delivery of her baby.

Outcome measures

Outcome measures
Measure	PrenaBelt n=14 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=9 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Body Position Sensor Participant Adherence	19 % of days Interval 13.0 to 40.0	33 % of days Interval 19.0 to 45.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.

Outcome measures

Outcome measures
Measure	PrenaBelt n=14 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=9 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Body Position Sensor Participant Time Used Per Night	5.3 hours Interval 4.7 to 5.6	5.4 hours Interval 4.2 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Throughout third trimester (on average, from 28 through 40 weeks gestation)

Population: Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.

Outcome measures

Outcome measures
Measure	PrenaBelt n=14 Participants Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=9 Participants Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Body Position Sensor Participant Sleep Time by Position Percentage sleep time left	27 % of total sleep time Interval 17.0 to 33.0	31 % of total sleep time Interval 30.0 to 36.0
Body Position Sensor Participant Sleep Time by Position Percentage sleep time right (%)	35 % of total sleep time Interval 28.0 to 39.0	34 % of total sleep time Interval 28.0 to 37.0
Body Position Sensor Participant Sleep Time by Position Percentage sleep time supine (%)	45 % of total sleep time Interval 33.0 to 49.0	37 % of total sleep time Interval 32.0 to 43.0

Adverse Events

PrenaBelt

Serious events: 6 serious events

Other events: 35 other events

Deaths: 0 deaths

Control

Serious events: 13 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PrenaBelt n=100 participants at risk Participants will be instructed to use the PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.	Control n=100 participants at risk Participants will be instructed to use the sham-PrenaBelt nightly for the remainder of their pregnancy in addition to receiving the local standard of care. A small subset of this group (n=16) will have a body position sensor (BPS) securely integrated into a small pocket on the sham-PrenaBelt. The BPS is not expected to affect body position or sleep. Participants will be followed by study personnel through the remainder of pregnancy and delivery.
Pregnancy, puerperium and perinatal conditions Stillbirth	2.0% 2/100 • Number of events 2 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Placental abruption	2.0% 2/100 • Number of events 2 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	2.0% 2/100 • Number of events 2 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Gastrointestinal disorders Acute gastroenteritis	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Intrauterine growth restriction	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Preeclampsia	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Severe preeclampsia	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Antepartum hemorrhage	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Failure to progress	3.0% 3/100 • Number of events 3 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	3.0% 3/100 • Number of events 3 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Imminent eclampsia	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	3.0% 3/100 • Number of events 3 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Persistent occiput posterior position	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Unfavourable cervix	0.00% 0/100 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.
Pregnancy, puerperium and perinatal conditions Neonatal Intensive Care Unit admission	1.0% 1/100 • Number of events 1 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.	2.0% 2/100 • Number of events 2 • September 7 2015 through May 13 2016. Participants were in the trial throughout the third trimester of pregnancy (28-40 weeks gestation), which is approximately 12 weeks. They were recruited between 26-30 weeks gestation and followed through the remainder of pregnancy (fortnightly from 28 weeks gestation until 36 weeks and then weekly until delivery), labor, and delivery. The mean number of days in the trial was 75.7 (standard deviation 16.7; minimum=25 days, maximum=119 days). Two arms: PrenaBelt (participants with and without the BPS) and Control (participants with and without the BPS). BPS was not expected to affect body position. We did not inappropriately combine the BPS and non-BPS arms of the PrenaBelt Arm and the Control Arm to turn four arms into two arms, and no arms are missing from the entered data. This was done for the sake of clarity.

Other adverse events

Additional Information

Dr. Allan Kember, Director of Programs

Global Innovations for Reproductive Health & Life

Phone: +1-902-580-8385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place