Trial Outcomes & Findings for KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section (NCT NCT03062228)
NCT ID: NCT03062228
Last Updated: 2020-03-31
Results Overview
At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
COMPLETED
162 participants
Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
2020-03-31
Participant Flow
Participants were recruited between April 28 2016 through February 22 2017, inclusive. Participants were recruited by the study recruiter from a sample of healthy, Ghanaian women presenting to the KBTH maternity wards and who delivered a live birth within the past 48 hours.
There were no significant events in the study after participant enrollment but prior to assignment to an arm or group. Two participants who were recruited were excluded from the study after it was discovered later that they did not fully meet the eligibility criteria (both had delivered stillborn infants).
Participant milestones
| Measure |
Controls
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants did not wish to disclose this information.
Baseline characteristics by cohort
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 4.4 • n=162 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=162 Participants
|
|
Race/Ethnicity, Customized
Ghanaian
|
162 Participants
n=162 Participants
|
|
Region of Enrollment
Ghana
|
162 Participants
n=162 Participants
|
|
Gravidity
Gravida 1
|
33 Participants
n=162 Participants
|
|
Gravidity
Gravida ≥2
|
129 Participants
n=162 Participants
|
|
Parity
Para 1
|
44 Participants
n=162 Participants
|
|
Parity
Para ≥2
|
118 Participants
n=162 Participants
|
|
Education level
Tertiary
|
21 Participants
n=162 Participants
|
|
Education level
Vocational
|
1 Participants
n=162 Participants
|
|
Education level
Senior High
|
52 Participants
n=162 Participants
|
|
Education level
Junior High
|
57 Participants
n=162 Participants
|
|
Education level
Primary
|
30 Participants
n=162 Participants
|
|
Education level
Undisclosed
|
1 Participants
n=162 Participants
|
|
Household Income
|
1144 Cedis per month
STANDARD_DEVIATION 665 • n=160 Participants • Two participants did not wish to disclose this information.
|
|
BMI upon entering third trimester for current pregnancy
|
27.7 kg/m^2
STANDARD_DEVIATION 4.1 • n=162 Participants
|
|
Pre-pregnancy BMI
|
25.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=162 Participants
|
|
Nightly sleep duration
|
8.3 hours
STANDARD_DEVIATION 1.5 • n=162 Participants
|
|
In the last week, sleep onset position
Left
|
75 Participants
n=162 Participants
|
|
In the last week, sleep onset position
Supine
|
11 Participants
n=162 Participants
|
|
In the last week, sleep onset position
Right
|
76 Participants
n=162 Participants
|
|
In the last week, sleep onset position
Prone
|
0 Participants
n=162 Participants
|
|
In the last week, waking position
Left
|
67 Participants
n=162 Participants
|
|
In the last week, waking position
Supine
|
25 Participants
n=162 Participants
|
|
In the last week, waking position
Right
|
70 Participants
n=162 Participants
|
|
In the last week, waking position
Prone
|
0 Participants
n=162 Participants
|
|
When not pregnant, sleep onset position
Left
|
1 Participants
n=162 Participants
|
|
When not pregnant, sleep onset position
Supine
|
87 Participants
n=162 Participants
|
|
When not pregnant, sleep onset position
Right
|
24 Participants
n=162 Participants
|
|
When not pregnant, sleep onset position
Prone
|
50 Participants
n=162 Participants
|
|
When not pregnant, waking position
Left
|
0 Participants
n=162 Participants
|
|
When not pregnant, waking position
Supine
|
97 Participants
n=162 Participants
|
|
When not pregnant, waking position
Right
|
31 Participants
n=162 Participants
|
|
When not pregnant, waking position
Prone
|
34 Participants
n=162 Participants
|
|
Part of bed sleeps on
Left
|
50 Participants
n=162 Participants
|
|
Part of bed sleeps on
Right
|
108 Participants
n=162 Participants
|
|
Part of bed sleeps on
Center
|
1 Participants
n=162 Participants
|
|
Part of bed sleeps on
Other
|
3 Participants
n=162 Participants
|
|
Pillow use
None
|
16 Participants
n=162 Participants
|
|
Pillow use
Under head
|
146 Participants
n=162 Participants
|
|
Pillow use
Between knees
|
1 Participants
n=162 Participants
|
|
Pillow use
Under tummy
|
0 Participants
n=162 Participants
|
|
Pillow use
Behind back
|
0 Participants
n=162 Participants
|
|
Pillow use
Pregnancy pillow
|
0 Participants
n=162 Participants
|
|
Pillow use
Under feet
|
37 Participants
n=162 Participants
|
|
Pillow use
Under legs
|
0 Participants
n=162 Participants
|
|
Sleeps with bed partner
|
119 Participants
n=162 Participants
|
|
Uses insecticide treated bed net
|
50 Participants
n=162 Participants
|
|
Snores ≥3 nights per week
|
12 Participants
n=162 Participants
|
|
Past medical complications
|
4 Participants
n=162 Participants
|
PRIMARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Birth Weight of Baby
|
3033 grams
Standard Deviation 514
|
PRIMARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method. The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Customized Birth Weight Centile
|
46.0 percentile
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
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
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Gestational Age at Delivery
|
38.3 Weeks
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Small for Gestational Age
|
25 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Low birth weight is defined has birth weight ≤ 2500 grams.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Low Birth Weight
|
21 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Sex of participant's newborn.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Sex of Newborn
Male
|
82 Participants
|
|
Sex of Newborn
Female
|
80 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Preterm delivery is defined as gestational age at birth \<37 weeks.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Preterm Delivery
|
42 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)Population: Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.
Mode of delivery (spontaneous vaginal, Cesarean section, instrumented) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Outcome measures
| Measure |
Controls
n=162 Participants
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital.
No interventions will be administered.
|
|---|---|
|
Mode of Delivery
Spontaneous vaginal
|
122 Participants
|
|
Mode of Delivery
Caesarean section
|
40 Participants
|
|
Mode of Delivery
Instrumented
|
0 Participants
|
Adverse Events
Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Allan Kember, Director of Programs
Global Innovations for Reproductive Health & Life
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place