Trial Outcomes & Findings for A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix (NCT NCT02901626)

Results Overview

Participants who either delivered or experienced a fetal death prior to 37 weeks gestation.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

544 participants

Primary outcome timeframe

Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.

Results posted on

2023-06-22

Participant Flow

From February 2017 through November 5, 2021 we conducted a multicenter randomized trial comparing the Arabin pessary versus usual care at 12 clinical centers. Individuals with asymptomatic singleton pregnancies who had a transvaginal cervical length \<20mm between 16 weeks 0 days and 23 weeks 6 days were identified per the local protocol for assessment of cervical length. People meeting eligibility requirements and accepting trial participation were randomized to either pessary or usual care.

Participant milestones

Participant milestones
Measure	Arabin Cervical Pessary Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Overall Study STARTED	280	264
Overall Study COMPLETED	279	263
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arabin Cervical Pessary Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Arabin Pessary n=280 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=264 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.	Total n=544 Participants Total of all reporting groups
Age, Continuous	29.9 years STANDARD_DEVIATION 6.0 • n=5 Participants	29.1 years STANDARD_DEVIATION 5.9 • n=7 Participants	29.5 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	280 Participants n=5 Participants	264 Participants n=7 Participants	544 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	132 Participants n=5 Participants	127 Participants n=7 Participants	259 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	61 Participants n=5 Participants	53 Participants n=7 Participants	114 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	62 Participants n=5 Participants	56 Participants n=7 Participants	118 Participants n=5 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other/not reported/unknown	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Gestational age at enrollment (weeks)	21.7 weeks n=5 Participants	21.9 weeks n=7 Participants	21.7 weeks n=5 Participants
Cervical length at screening (mm)	12.7 mm STANDARD_DEVIATION 5.2 • n=5 Participants	12.7 mm STANDARD_DEVIATION 5.3 • n=7 Participants	12.7 mm STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.

Population: 1 participant in each group was lost to follow-up

Participants who either delivered or experienced a fetal death prior to 37 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.	127 Participants	120 Participants

SECONDARY outcome

Timeframe: from randomization to delivery or fetal death (up to a length of 189 days)

The median interval between randomization to delivery or death of the fetus.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Interval From Randomization to Delivery or Fetal Death	105 days Interval 42.0 to 120.0	103 days Interval 56.0 to 118.0

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

Median gestational age (in weeks) at the time of delivery

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Gestational Age at Delivery	37.3 weeks Interval 27.4 to 39.1	37.4 weeks Interval 29.6 to 39.1

SECONDARY outcome

Timeframe: from randomization to less than 28 weeks gestation (a period of less than 91 days)

The number of participants who either delivered or experienced a fetal death prior to 28 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Preterm Delivery or Fetal Death at Less Than 28 Weeks Gestation	72 Participants	54 Participants

SECONDARY outcome

Timeframe: from randomization to less than 32 weeks gestation (a period of less than 119 days)

The number of participants who either delivered or experienced a fetal death prior to 32 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Preterm Delivery or Fetal Death at Less Than 32 Weeks Gestation	93 Participants	73 Participants

SECONDARY outcome

Timeframe: from randomization to less than 35 weeks gestation (a period of less than 140 days)

The number of participants who either delivered or experienced a fetal death prior to 35 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Preterm Delivery or Fetal Death at Less Than 35 Weeks Gestation	111 Participants	90 Participants

SECONDARY outcome

Timeframe: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment

Population: Data is missing for 2 participants in the pessary group and 5 participants in the no pessary group.

Participants were categorized as yes if the amniotic membranes ruptured prior to labor onset and before 37 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=277 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=258 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Preterm Premature Rupture of Membranes	64 Participants	46 Participants

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

The number of participants who experienced spontaneous onset of labor and had an unassisted vaginal delivery prior to 37 weeks gestation. Induction for delivery was not performed and operative techniques such as forceps or vacuum were not used.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Spontaneous Preterm Delivery.	109 Participants	106 Participants

SECONDARY outcome

Timeframe: from randomization to delivery (up to a length of 189 days)

The number of participants who underwent labor induction or had an assisted vaginal delivery with forceps or vacuum or cesarean delivery prior to 37 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Indicated Preterm Delivery	18 Participants	14 Participants

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

The number of participants who underwent a surgical procedure for delivery (cesarean) at any gestational age.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Cesarean Delivery	86 Participants	80 Participants

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

The number of participants who had a clinical diagnosis of chorioamnionitis and a body temperature of at least 100.0° F (38° C) and no other defined infection.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Chorioamnionitis	18 Participants	16 Participants

SECONDARY outcome

Timeframe: from date of admission for delivery up to delivery date (up to 5 days)

Median number of days from maternal hospital admission for delivery and the date of delivery.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=279 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=263 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Median Length of Maternal Antepartum Hospital Stay Before Delivery	1 days Interval 0.0 to 1.0	1 days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

Population: Data missing for 53 participants in the pessary group and 43 participants in the no pessary group.

The number of participants with a clinical diagnosis of a vaginal infection. Includes participants with at least one study visit.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=226 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=220 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants With Vaginal Infection	57 Participants	41 Participants

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

Population: Data missing for 53 participants in the pessary group and 43 participants in the no pessary group.

The number of participants who received antibiotics or antifungal medication for a vaginal infection (out of the total sample for which data is available)

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=226 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=220 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
The Number of Participants Who Had a Vaginal Infection and Received Antibiotic Treatment, Among All Persons Enrolled With at Least One Study Visit	55 Participants	37 Participants

SECONDARY outcome

Timeframe: From randomization to delivery (up to a length of 189 days)

Population: Data missing for 21 participants in the pessary group and 13 participants in the no pessary group.

The number of participants who received any one of the following treatments for preterm labor: tocolysis, cerclage, bedrest, antenatal corticosteroids for fetal lung maturity, or magnesium sulfate for neuroprotection.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=258 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=250 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Participants Treated for Preterm Labor Including Placement of Cerclage	150 Participants	143 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

Median number of days a neonate or infant was on a ventilator or received continuous positive airway pressure.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=97 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=104 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Median Duration of Neonatal Ventilator or Continuous Positive Airway Pressure Use	6 days Interval 0.0 to 43.0	5 days Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates missing date in the pessary group

The number of neonates or infants who required ventilator support or received continuous positive airway pressure.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use	75 Participants	82 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

Median number of days a neonate received supplemental oxygen after admission to the NICU or intermediate nursery. Supplemental oxygen is defined as FiO2 \> 0.21.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=95 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=105 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Median Duration (in Days) of Neonatal Supplemental Oxygen Use	7 days Interval 0.0 to 41.0	6 days Interval 0.0 to 51.0

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates with a clinical diagnosis of seizures who received anti-seizure medication.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Seizures Requiring Treatment	1 Participants	1 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates whose birthweight compared with gestational age at delivery was less than the 5th percentile, as assessed by sex and race, using United States birth certificate data.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=258 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=253 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates Small for Gestational Age < 5th Percentile	5 Participants	6 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). there are 3 neonates with missing data in the pessary group.

IVH grades III or IV are as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=258 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV	4 Participants	7 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates in the pessary group are missing data.

The number of neonates with a clinical diagnosis of retinopathy of prematurity where an ophthalmologic examination of the retina was performed.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Retinopathy of Prematurity (ROP)	27 Participants	23 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates in the pessary group are missing data

The number of neonates with a diagnosis of respiratory distress syndrome defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with oxygen requirement and a chest x-ray that show hypoaeration and reticulogranular infiltrates.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates Experiencing Respiratory Distress Syndrome (RDS)	67 Participants	69 Participants

SECONDARY outcome

Timeframe: Delivery through 28 days of life if delivered at or after 32 weeks. Delivery through 36 weeks gestation if delivered before 32 weeks.

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates with a clinical diagnosis of bronchopulmonary dysplasia defined as oxygen requirement at 28 days of life if delivered at or after 32 weeks gestation, or at 36 weeks project gestational age if delivered before 32 weeks gestation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=260 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Bronchopulmonary Dysplasia (BPD)	14 Participants	19 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates diagnosed with NEC, defined as modified Bell Stage 2 or 3 where stage 2 represents clinical signs and symptoms with pneumatosis intestinalis on radiographs and stage 3 is defined as advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3	7 Participants	6 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates missing data in the pessary group. 1 neonate missing data in the no pessary group.

The number of neonates diagnosed with hyperbilirubinemia, defined as peak total bilirubin of at least 15 mg% or the use of phototherapy

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=253 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Hyperbilirubinemia	84 Participants	82 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates missing data in the pessary group

The number of neonates diagnosed with any one of the following: * Sepsis (within 72 hours and \> 72 hours after birth) defined as a clinically ill infant in whom systemic infection is suspected with a positive blood, CSF, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection. * Suspected sepsis. The diagnosis of suspected sepsis will include infants with suspicious clinical findings of infection, but no positive cultures or radiographs. * Pneumonia. The diagnosis of pneumonia will be confirmed by radiograph or positive blood culture.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia	53 Participants	65 Participants

SECONDARY outcome

Timeframe: within 72 hours of birth

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates with a clinical diagnosis of sepsis within 72 hours of life, defined as a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Early Onset Sepsis	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 72 hours of birth or later (up to hospital discharge - a maximum of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates with a clinical diagnosis of sepsis at or after 72 hours of life, defined as the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal radiograph confirming infection.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Late Onset Sepsis	8 Participants	12 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 2 neonates missing data in the pessary group.

The number of neonates with suspicious clinical findings of infection, but no positive cultures or radiographs.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Suspected Sepsis	38 Participants	51 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

The number of neonates with a clinical diagnosis of pneumonia within 72 hours of birth and confirmed by either an x-ray demonstrating consolidation with air bronchograms, or a positive blood culture performed at the time of clinical diagnosis.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=259 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Pneumonia	2 Participants	4 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9). 1 neonate missing data in the pessary group

The number of neonates diagnosed with any one of fetal or neonatal death or Respiratory Distress Syndrome, Grade 3 or 4 Intraventricular Hemorrhage, Periventricular Leukomalacia, Stage 2 or 3 Nectrotizing Enterocolitis, Bronchopulmonary Dysplasia, Stage III or higher Retinopathy of Prematurity, or early onset sepsis.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=260 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=254 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Number of Neonates With Composite Outcome	81 Participants	74 Participants

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

Median number of days the neonate/infant remained in hospital.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=258 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=253 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Median Length of Neonatal Hospital Stay	3 days Interval 2.0 to 20.0	3 days Interval 2.0 to 22.0

SECONDARY outcome

Timeframe: delivery through hospital discharge (up to a length of 435 days)

Population: among livebirth deliveries (excludes fetal deaths - pessary 18, no pessary 9)

Median number of days the neonate/infant remained in the neonatal intensive care unit or special care nursery.

Outcome measures

Outcome measures
Measure	Cervical Arabin Pessary n=97 Participants Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care. Pessary: The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study: Pessary Size upper diameter, lower diameter 1. Nulliparous 65 mm, 32 mm 2. Multiparous 70 mm, 32 mm 3. Alternative 70 mm, 35 mm	No Pessary n=104 Participants Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Median Number of Days in Neonatal Intensive Care Unit (NICU)	50 days Interval 10.0 to 99.0	37 days Interval 11.0 to 88.0

Adverse Events

Cervical Arabin Pessary

Serious events: 13 serious events

Other events: 248 other events

Deaths: 37 deaths

No Pessary

Serious events: 17 serious events

Other events: 200 other events

Deaths: 18 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cervical Arabin Pessary n=280 participants at risk Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.	No Pessary n=264 participants at risk Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Pregnancy, puerperium and perinatal conditions Vaginal fluid leakage	9.3% 26/280 • Number of events 27 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	0.76% 2/264 • Number of events 2 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Lower abdominal/pelvic pain	28.2% 79/280 • Number of events 118 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	30.3% 80/264 • Number of events 124 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Lower abdominal/pelvic pressure	36.8% 103/280 • Number of events 190 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	33.7% 89/264 • Number of events 165 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Urinary change in frequency and incontinence	18.9% 53/280 • Number of events 78 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	14.0% 37/264 • Number of events 53 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal bleeding	5.0% 14/280 • Number of events 14 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	5.7% 15/264 • Number of events 15 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal burning	7.5% 21/280 • Number of events 27 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	6.1% 16/264 • Number of events 19 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal discharge	71.8% 201/280 • Number of events 477 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	60.6% 160/264 • Number of events 321 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal discomfort/soreness	36.1% 101/280 • Number of events 175 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	26.1% 69/264 • Number of events 119 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal itching	16.1% 45/280 • Number of events 72 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	9.8% 26/264 • Number of events 38 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.
Pregnancy, puerperium and perinatal conditions Vaginal odor	19.3% 54/280 • Number of events 84 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.	9.5% 25/264 • Number of events 47 • Adverse events were collected from from delivery (up to 175 days after randomization) through hospital discharge of the neonate (up to a length of 435 days). All cause mortality was assessed from delivery to 28 days after the expected date of delivery, if discharged from hospital on or before 28 days after the expected date of delivery. If discharged from hospital after 28 days after the expected date of delivery, all cause mortality was assessed from delivery to hospital discharge.

Additional Information

Matthew Hoffman, MD, MPH

Christiana Care Health System, Department of Obstetrics & Gynecology

Phone: (302) 301-3350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER