A Phase 3 interventional study of Arabin Cervical Pessary in Short Cervix and Preterm Delivery, sponsored by The George Washington University Biostatistics Center. Terminated at 12 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by The George Washington University Biostatistics Center · Phase 3, Interventional, and Prevention
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Among 742 studies in Premature Birth with a site in United States — 104 open to participants now, 136 under way, 9 of them phase 3. Premature Birth · United States.
Among the 742 studies in Premature Birth with a site in United States, this one is the 64th largest by enrollment of the 529 interventional ones that give a count, is one of 41 that started in 2017, is one of 49 in phase 3, and was the 418th registered.
2,554 studies on the registry are indexed under Premature Birth; 503 are open to participants now.
Browse Premature Birth studies →104 of the 742 studies in Premature Birth with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
University of South Carolina · Sites in United States
Ages 18+ · Women only
Columbia University · Sites in United States
Ages 18–40 · Women only
University of Alabama at Birmingham · Sites in United States
Ages 1 days–3 days
The University of Texas Medical Branch, Galveston · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: female · healthy volunteers too.
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742 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 49 · Phase 2 68 · Phase 3 66 · Phase 4 23
First in 1987; this study’s year is marked. 41 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 544 is above the median of 84 across 1,670 interventional studies indexed under Premature Birth.
Median enrollment 85 across the 529 interventional studies, 104 across the 209 observational. Of the 542 that completed or were terminated, 145 (27%) have results posted.
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74 of 742 have an industry lead sponsor. The 10 most frequent:
The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
The George Washington University Biostatistics Center has 9 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
46 of the studies in Premature Birth with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04614714Phase 3University of California, DavisMilk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants | 2027-08-30 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT01483079Baylor College of MedicinePost-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU) | 2026-12 |
| NCT07674953University of ArkansasHow Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants | 2026-12 |
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Among the 742 studies in Premature Birth with a site in United States, from their registry updates:
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The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.
While cervical length is one of the most powerful predictors of subsequent preterm birth, the best treatment to reduce subsequent preterm birth remains unknown. This study is a randomized trial of women who have a singleton pregnancy and a short cervical length on transvaginal ultrasound as determined by a study-certified sonographer. It is being conducted at 12 clinical centers across the country and the recruitment target is enrollment of 850 pregnant women. Participants will be randomized to 1) Arabin pessary or 2) usual care as per by local hospital protocol. Pessary is a promising low-cost, non-surgical intervention that appears to be well-tolerated. The pessary will be placed by obstetric providers trained in appropriate placement of the Arabin pessary. The primary outcome of the study is delivery or fetal death prior to 37 weeks 0 days gestational age.
In the literature, there are two large trials that have produced conflicting results (M Goya et al, 2012, K Nicolaides et al, 2016). Thus, the results of an adequately powered and appropriately conducted trial from the United States will be important in determining whether pessary is a useful intervention for the prevention of subsequent preterm birth in women with singleton gestation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arabin pessary. Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
Device: Arabin Cervical Pessary
Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.
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
Also known as: Arabin pessary
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.
Time frame: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.
Interval From Randomization to Delivery or Fetal Death
The median interval between randomization to delivery or death of the fetus.
Time frame: from randomization to delivery or fetal death (up to a length of 189 days)
Gestational Age at Delivery
Median gestational age (in weeks) at the time of delivery
Time frame: From randomization to delivery (up to a length of 189 days)
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.
Time frame: from randomization to less than 28 weeks gestation (a period of less than 91 days)
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.
Time frame: from randomization to less than 32 weeks gestation (a period of less than 119 days)
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.
Time frame: from randomization to less than 35 weeks gestation (a period of less than 140 days)
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.
Time frame: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment
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.
Time frame: From randomization to delivery (up to a length of 189 days)
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.
Time frame: from randomization to delivery (up to a length of 189 days)
Number of Participants With Cesarean Delivery
The number of participants who underwent a surgical procedure for delivery (cesarean) at any gestational age.
Time frame: From randomization to delivery (up to a length of 189 days)
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.
Time frame: From randomization to delivery (up to a length of 189 days)
Median Length of Maternal Antepartum Hospital Stay Before Delivery
Median number of days from maternal hospital admission for delivery and the date of delivery.
Time frame: from date of admission for delivery up to delivery date (up to 5 days)
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.
Time frame: From randomization to delivery (up to a length of 189 days)
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)
Time frame: From randomization to delivery (up to a length of 189 days)
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.
Time frame: From randomization to delivery (up to a length of 189 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
Number of Neonates With Seizures Requiring Treatment
The number of neonates with a clinical diagnosis of seizures who received anti-seizure medication.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: Delivery through 28 days of life if delivered at or after 32 weeks. Delivery through 36 weeks gestation if delivered before 32 weeks.
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: within 72 hours of birth
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.
Time frame: 72 hours of birth or later (up to hospital discharge - a maximum of 435 days)
Number of Neonates With Suspected Sepsis
The number of neonates with suspicious clinical findings of infection, but no positive cultures or radiographs.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
Median Length of Neonatal Hospital Stay
Median number of days the neonate/infant remained in hospital.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: delivery through hospital discharge (up to a length of 435 days)
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.
Time frame: Before 37 weeks 0 days gestation, a period of up to 21 weeks from enrollment.
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.
| Milestone | Arabin Cervical Pessary | No Pessary |
|---|---|---|
| Started | 280 | 264 |
| Completed | 279 | 263 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
Participants who either delivered or experienced a fetal death prior to 37 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks. | 127 | 120 |
The median interval between randomization to delivery or death of the fetus.
| days | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Interval From Randomization to Delivery or Fetal Death | 105 (42 to 120) | 103 (56 to 118) |
Median gestational age (in weeks) at the time of delivery
| weeks | Arabin Cervical Pessary | No Pessary |
|---|---|---|
| Gestational Age at Delivery | 37.3 (27.4 to 39.1) | 37.4 (29.6 to 39.1) |
The number of participants who either delivered or experienced a fetal death prior to 28 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Preterm Delivery or Fetal Death at Less Than 28 Weeks Gestation | 72 | 54 |
The number of participants who either delivered or experienced a fetal death prior to 32 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Preterm Delivery or Fetal Death at Less Than 32 Weeks Gestation | 93 | 73 |
The number of participants who either delivered or experienced a fetal death prior to 35 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Preterm Delivery or Fetal Death at Less Than 35 Weeks Gestation | 111 | 90 |
Participants were categorized as yes if the amniotic membranes ruptured prior to labor onset and before 37 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Preterm Premature Rupture of Membranes | 64 | 46 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Spontaneous Preterm Delivery. | 109 | 106 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Indicated Preterm Delivery | 18 | 14 |
The number of participants who underwent a surgical procedure for delivery (cesarean) at any gestational age.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Cesarean Delivery | 86 | 80 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Chorioamnionitis | 18 | 16 |
Median number of days from maternal hospital admission for delivery and the date of delivery.
| days | Pessary | No Pessary |
|---|---|---|
| Median Length of Maternal Antepartum Hospital Stay Before Delivery | 1 (0 to 1) | 1 (0 to 1) |
The number of participants with a clinical diagnosis of a vaginal infection. Includes participants with at least one study visit.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants With Vaginal Infection | 57 | 41 |
The number of participants who received antibiotics or antifungal medication for a vaginal infection (out of the total sample for which data is available)
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| The Number of Participants Who Had a Vaginal Infection and Received Antibiotic Treatment, Among All Persons Enrolled With at Least One Study Visit | 55 | 37 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Participants Treated for Preterm Labor Including Placement of Cerclage | 150 | 143 |
Median number of days a neonate or infant was on a ventilator or received continuous positive airway pressure.
| days | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Median Duration of Neonatal Ventilator or Continuous Positive Airway Pressure Use | 6 (0 to 43) | 5 (0 to 41) |
The number of neonates or infants who required ventilator support or received continuous positive airway pressure.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use | 75 | 82 |
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.
| days | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Median Duration (in Days) of Neonatal Supplemental Oxygen Use | 7 (0 to 41) | 6 (0 to 51) |
The number of neonates with a clinical diagnosis of seizures who received anti-seizure medication.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Seizures Requiring Treatment | 1 | 1 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates Small for Gestational Age < 5th Percentile | 5 | 6 |
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
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV | 4 | 7 |
The number of neonates with a clinical diagnosis of retinopathy of prematurity where an ophthalmologic examination of the retina was performed.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Retinopathy of Prematurity (ROP) | 27 | 23 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates Experiencing Respiratory Distress Syndrome (RDS) | 67 | 69 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Bronchopulmonary Dysplasia (BPD) | 14 | 19 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3 | 7 | 6 |
The number of neonates diagnosed with hyperbilirubinemia, defined as peak total bilirubin of at least 15 mg% or the use of phototherapy
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Hyperbilirubinemia | 84 | 82 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia | 53 | 65 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Early Onset Sepsis | 5 | 2 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Late Onset Sepsis | 8 | 12 |
The number of neonates with suspicious clinical findings of infection, but no positive cultures or radiographs.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Suspected Sepsis | 38 | 51 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Pneumonia | 2 | 4 |
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.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Number of Neonates With Composite Outcome | 81 | 74 |
Median number of days the neonate/infant remained in hospital.
| days | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Median Length of Neonatal Hospital Stay | 3 (2 to 20) | 3 (2 to 22) |
Median number of days the neonate/infant remained in the neonatal intensive care unit or special care nursery.
| days | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Median Number of Days in Neonatal Intensive Care Unit (NICU) | 50 (10 to 99) | 37 (11 to 88) |
NIH-required analysis. Number of participants who either delivered or experienced a fetal death prior to 37 weeks gestation.
| Participants | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Non-Hispanic black | 61 | 57 |
| Non-Hispanic white | 25 | 27 |
| Hispanic | 28 | 28 |
| Asian | 6 | 2 |
| Native Hawaiian / Pacific Islander | 0 | 1 |
| American Indian | 1 | 0 |
| Other / not reported / unknown | 6 | 5 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervical Arabin Pessary | 37/280 (13.2%) | 13/280 (4.6%) | 248/280 (88.6%) |
| No Pessary | 18/264 (6.8%) | 17/264 (6.4%) | 200/264 (75.8%) |
| Event | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 1/280 | 2/264 |
| Post-partum hemorrhagePregnancy, puerperium and perinatal conditions | 2/280 | 1/264 |
| Hypertension ManagementVascular disorders | 0/280 | 1/264 |
| Neonatal ventricular septal defectVascular disorders | 1/280 | 1/264 |
| Neonatal intestinal failureGastrointestinal disorders | 0/280 | 1/264 |
| Glucoregulation in the setting of steroid administrationEndocrine disorders | 0/280 | 1/264 |
| Sars-CoV-2 InfectionRespiratory, thoracic and mediastinal disorders | 0/280 | 1/264 |
| Hospital-based pneumoniaRespiratory, thoracic and mediastinal disorders | 0/280 | 1/264 |
| Neonatal central nervous system malformationCongenital, familial and genetic disorders | 0/280 | 1/264 |
| Neonatal amputationSkin and subcutaneous tissue disorders | 0/280 | 1/264 |
| Event | Cervical Arabin Pessary | No Pessary |
|---|---|---|
| Vaginal dischargePregnancy, puerperium and perinatal conditions | 201/280 | 160/264 |
| Lower abdominal/pelvic pressurePregnancy, puerperium and perinatal conditions | 103/280 | 89/264 |
| Vaginal discomfort/sorenessPregnancy, puerperium and perinatal conditions | 101/280 | 69/264 |
| Lower abdominal/pelvic painPregnancy, puerperium and perinatal conditions | 79/280 | 80/264 |
| Vaginal odorPregnancy, puerperium and perinatal conditions | 54/280 | 25/264 |
| Urinary change in frequency and incontinencePregnancy, puerperium and perinatal conditions | 53/280 | 37/264 |
| Vaginal itchingPregnancy, puerperium and perinatal conditions | 45/280 | 26/264 |
| Vaginal fluid leakagePregnancy, puerperium and perinatal conditions | 26/280 | 2/264 |
| Vaginal burningPregnancy, puerperium and perinatal conditions | 21/280 | 16/264 |
| Vaginal bleedingPregnancy, puerperium and perinatal conditions | 14/280 | 15/264 |
| Age, Continuous(years) | Cervical Arabin Pessary | No Pessary | Total |
|---|---|---|---|
| Mean | 29.9 ± 6.0 | 29.1 ± 5.9 | 29.5 ± 6.0 |
| Sex: Female, Male(Participants) | Cervical Arabin Pessary | No Pessary | Total |
|---|---|---|---|
| Female | 280 | 264 | 544 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cervical Arabin Pessary | No Pessary | Total |
|---|---|---|---|
| Non-Hispanic Black | 132 | 127 | 259 |
| Non-Hispanic White | 61 | 53 | 114 |
| Hispanic | 62 | 56 | 118 |
| Asian | 12 | 16 | 28 |
| Native Hawaiian/Pacific Islander | 0 | 1 | 1 |
| American Indian | 1 | 0 | 1 |
| Other/not reported/unknown | 12 | 11 | 23 |
| Gestational age at enrollment (weeks)(weeks) | Cervical Arabin Pessary | No Pessary | Total |
|---|---|---|---|
| Median | 21.7 (20.6 to 22.9) | 21.9 (20.7 to 23.2) | 21.7 (20.7 to 23.0) |
| Cervical length at screening (mm)(mm) | Cervical Arabin Pessary | No Pessary | Total |
|---|---|---|---|
| Mean | 12.7 ± 5.2 | 12.7 ± 5.3 | 12.7 ± 5.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data will be shared after the completion of the trial and publication of the main analyses per NIH policy. Data will be available through the NICHD Data and Specimen Hub
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Ran from Feb 2017 to primary completion in Apr 2022, 61 months.
Results were first posted in Jun 2023, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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The George Washington University Biostatistics Center