A Randomized Trial of Pessary in Singleton Pregnancies Wi... | NCT02901626

ID	Type	Link
UG1HD087230	U.S. NIH Grant/Contract	View source
UG1HD027915	U.S. NIH Grant/Contract	View source
UG1HD034208	U.S. NIH Grant/Contract	View source
UG1HD040500	U.S. NIH Grant/Contract	View source
UG1HD040485	U.S. NIH Grant/Contract	View source
UG1HD053097	U.S. NIH Grant/Contract	View source
UG1HD040544	U.S. NIH Grant/Contract	View source
UG1HD040545	U.S. NIH Grant/Contract	View source
UG1HD040560	U.S. NIH Grant/Contract	View source
UG1HD040512	U.S. NIH Grant/Contract	View source
UG1HD087192	U.S. NIH Grant/Contract	View source
U24HD036801	U.S. NIH Grant/Contract	View source
UG1HD027869	U.S. NIH Grant/Contract	View source

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Label	Type	Description	Intervention Names
Arabin Cervical Pessary	Experimental	Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.	Device: Arabin Cervical Pessary
No Pessary	No Intervention	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Name	Type	Description	Arm Group Labels	Other Names
Arabin Cervical Pessary	Device	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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm

Measure	Description	Time Frame
Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.	Participants who either delivered or experienced a fetal death prior to 37 weeks gestation.	Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.

Measure	Description	Time Frame
Interval From Randomization to Delivery or Fetal Death	The median interval between randomization to delivery or death of the fetus.	from randomization to delivery or fetal death (up to a length of 189 days)
Gestational Age at Delivery

Measure	Description	Time Frame
Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks by Race/Ethnicity	NIH-required analysis. Number of participants who either delivered or experienced a fetal death prior to 37 weeks gestation.	Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.

Name	Affiliation	Role
Rebecca Clifton, Ph.D.	George Washington University Biostatistics Center	Principal Investigator
Monica Longo, MD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Study Director
Matthew Hoffman, MD	Christiana Care Health Services	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama - Birmingham		Birmingham	Alabama	35233	United States
Northwestern University

PubMed Identifier	Type	Citation	Retractions
26727629	Background	Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
21094412	Background	Lawn JE, Kerber K, Enweronu-Laryea C, Cousens S. 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol. 2010 Dec;34(6):371-86. doi: 10.1053/j.semperi.2010.09.011.

ID	Title	Description
FG000	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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Jun 15, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.

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

1 participant in each group was lost to follow-up

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants	OG000279 OG001263

Title

Denominators

Categories

Title	Measurements
	OG000127 OG001120

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Ratio (RR)	1.0			2-Sided	95	0.83	1.20					Superiority

Secondary

Interval From Randomization to Delivery or Fetal Death

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Gestational Age at Delivery

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

Posted

Median

Inter-Quartile Range

weeks

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

ID	Title	Description
OG000	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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Preterm Delivery or Fetal Death at Less Than 28 Weeks Gestation

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Preterm Delivery or Fetal Death at Less Than 32 Weeks Gestation

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Preterm Delivery or Fetal Death at Less Than 35 Weeks Gestation

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Preterm Premature Rupture of Membranes

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

Number of Participants With Spontaneous Preterm Delivery.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Indicated Preterm Delivery

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Cesarean Delivery

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Chorioamnionitis

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Median Length of Maternal Antepartum Hospital Stay Before Delivery

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Participants With Vaginal Infection

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

The Number of Participants Who Had a Vaginal Infection and Received Antibiotic Treatment, Among All Persons Enrolled With at Least One Study Visit

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Participants Treated for Preterm Labor Including Placement of Cerclage

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Median Duration of Neonatal Ventilator or Continuous Positive Airway Pressure Use

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

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

Median Duration (in Days) of Neonatal Supplemental Oxygen Use

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.

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

Number of Neonates With Seizures Requiring Treatment

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Number of Neonates Small for Gestational Age < 5th Percentile

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units

Secondary

Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin Pessary	Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of . 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Retinopathy of Prematurity (ROP)

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units

Secondary

Number of Neonates Experiencing Respiratory Distress Syndrome (RDS)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Bronchopulmonary Dysplasia (BPD)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Hyperbilirubinemia

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

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001

Secondary

Number of Neonates With Early Onset Sepsis

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.

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

Posted

Count of Participants

Participants

within 72 hours of birth

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Late Onset Sepsis

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Suspected Sepsis

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

Secondary

Number of Neonates With Pneumonia

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Number of Neonates With Composite Outcome

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Secondary

Median Length of Neonatal Hospital Stay

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

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Secondary

Median Number of Days in Neonatal Intensive Care Unit (NICU)

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

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

Posted

Median

Inter-Quartile Range

days

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks by Race/Ethnicity

NIH-required analysis. Number of participants who either delivered or experienced a fetal death prior to 37 weeks gestation.

Primary outcome stratified by race/ethnicity categories

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
OG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Units	Counts

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cervical Arabin Pessary	Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.	37	280	13	280	248	280
EG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.	18	264	17	264	200	264

Term	Organ System	Assessment Type	Notes	Statistical Information
Hypertension Management	Vascular disorders	Non-systematic Assessment	hospitalized for adjustment of BP meds after not taking meds as prescribed	EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Neonatal ventricular septal defect	Vascular disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0011 events1 affected264 at risk
Neonatal intestinal failure	Gastrointestinal disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Glucoregulation in the setting of steroid administration	Endocrine disorders	Non-systematic Assessment	hospitalized for management of gestational diabetes (along with antenatal corticosteroids)	EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Hyperbilirubinemia	Hepatobiliary disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Hyperbilirubinemia and weight loss	Hepatobiliary disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Sars-CoV-2 Infection	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	maternal COVID-19 infection	EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Hospital-based pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Meconium aspiration syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Respiratory syncytial virus/ bronchiolitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Neonatal central nervous system malformation	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Chorioamnionitis	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Ambiguous genitalia	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Craniosynostosis	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Hypospadias	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Post-partum hemorrhage	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG0002 events2 affected280 at risk EG0011 events1 affected264 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0012 events2 affected264 at risk
Neonatal amputation	Skin and subcutaneous tissue disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Polydactyly	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Auditory hallucination	Psychiatric disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Chronic multifocal osteomyelitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Neonatal CN6 Palsy	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Disseminated herpes simplex virus	Infections and infestations	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Erb-Duchenne Palsy	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Neonatal hematoma	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Pelvic hematoma	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk
Trisomy 21	Congenital, familial and genetic disorders	Non-systematic Assessment		EG0001 events1 affected280 at risk EG0010 events0 affected264 at risk
Necrotizing enterocolitis	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected280 at risk EG0011 events1 affected264 at risk

Term	Organ System	Assessment Type	Statistical Information
Vaginal fluid leakage	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00027 events26 affected280 at risk EG0012 events2 affected264 at risk
Lower abdominal/pelvic pain	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG000118 events79 affected280 at risk EG001124 events80 affected264 at risk
Lower abdominal/pelvic pressure	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG000190 events103 affected280 at risk EG001165 events89 affected264 at risk
Urinary change in frequency and incontinence	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00078 events53 affected280 at risk EG00153 events37 affected264 at risk
Vaginal bleeding	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00014 events14 affected280 at risk EG00115 events15 affected264 at risk
Vaginal burning	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00027 events21 affected280 at risk EG00119 events16 affected264 at risk
Vaginal discharge	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG000477 events201 affected280 at risk EG001321 events160 affected264 at risk
Vaginal discomfort/soreness	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG000175 events101 affected280 at risk EG001119 events69 affected264 at risk
Vaginal itching	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00072 events45 affected280 at risk EG00138 events26 affected264 at risk
Vaginal odor	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG00084 events54 affected280 at risk EG00147 events25 affected264 at risk

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Title	Description
BG000	Cervical Arabin 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 Nulliparous 65 mm, 32 mm Multiparous 70 mm, 32 mm Alternative 70 mm, 35 mm
BG001	No Pessary	Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
BG002	Total	Total of all reporting groups