TerminatedNCT02901626TOPSUpdated Jun 23, 2026Results posted

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

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

Why this study was terminated

The study was stopped per the recommendation of the DSMB and NICHD.

Phase: Phase 3
Study type: Interventional
Enrollment: 544
Allocation: Randomized
Sex: Female

Study summary

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.

Read the detailed description

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.

Conditions studied

Short Cervix
Preterm Delivery

Browse trials for

Premature Birth 2,549

Keywords

Short cervix
Preterm delivery
Singletons
Pregnancy
Pessary

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Singleton gestation. Twin gestation reduced to singleton either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher order multifetal gestations reduced to singletons are not eligible.
Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
Cervical length on transvaginal examination of less than or equal to 20 mm by a study certified sonographer. There is no lower cervical length threshold.

Exclusion criteria

Exclusion Criteria:

Cervical dilation (internal os) 3 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization.
Fetal anomaly or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, serious karyotypic abnormalities. An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project Estimated Date of Confinement (EDC) must be performed prior to randomization to evaluate the fetus for anomalies.
Previous spontaneous preterm birth between 16 weeks 0 days and 36 weeks 6 days. This includes induction for pPROM in a prior pregnancy.
Planned treatment with intramuscular 17-α hydroxy-progesterone caproate.
Placenta previa, because of risk of bleeding and high potential for indicated preterm birth. A low lying placenta is acceptable.
Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement.
Symptomatic, untreated vaginal or cervical infection because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized. However, if it is more than 10 days since the cervical length measurement, a new cervical length measurement must be obtained.
Active, unhealed herpetic lesion on labia minora, vagina, or cervix due to the potential for significant patient discomfort or increasing genital tract viral spread. Once lesion(s) heal and the patient is asymptomatic, she may be randomized. History of herpes is not an exclusion.
Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement.
More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer.
Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone.
Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.
Major maternal medical illness associated with increased risk for adverse pregnancy outcome or indicated preterm birth (treated hypertension requiring more than one agent, treatment for diabetes prior to pregnancy, chronic renal insufficiency defined by creatinine >1.4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy). Lupus, uncontrolled thyroid disease, and New York Heart Association(NYHA) stage II or greater cardiac disease are also excluded. Patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/Loop Electrocautery Excision Procedure (LEEP) is not an exclusion criterion.
Planned cerclage or cerclage already in place since it would preclude placement of a pessary.
Planned indicated delivery prior to 37 weeks.
Allergy to silicone.
Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality.
Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 544 participants (actual)

Study arms

Experimental
Arabin Cervical Pessary
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 intervention
No Pessary
Participants will also receive vaginal progesterone to be administered daily, if it is the local standard of care.

Interventions

DeviceArabin Cervical 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
Also known as: Arabin pessary

What researchers measure

Primary outcomes

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.

Secondary outcomes

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)

Other outcomes

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.

Results

Posted Jun 22, 2023

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 flow — Overall Study
Milestone	Arabin Cervical Pessary	No Pessary
Started	280	264
Completed	279	263
Not completed	1	1
Withdrew: Lost to follow-up	1	1

Outcome measures

PrimaryNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Preterm Delivery or Fetal Death at Less Than 37 Weeks.	127	120

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.0 · 95% CI 0.83 to 1.20

SecondaryInterval 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)
Reported as:: Median · days

Interval From Randomization to Delivery or Fetal Death
days	Cervical Arabin Pessary	No Pessary
Interval From Randomization to Delivery or Fetal Death	105 (42 to 120)	103 (56 to 118)

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Median difference (net): 2 · 95% CI -4 to 8

SecondaryGestational 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)
Reported as:: Median · weeks

Gestational Age at 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)

Statistical analysis

Arabin Cervical Pessary vs No Pessary · Mean difference (net): -0.1 · 95% CI -1.06 to 0.80

SecondaryNumber 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)
Reported as:: Count of participants · Participants

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

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.26 · 95% CI 0.92 to 1.71

SecondaryNumber 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)
Reported as:: Count of participants · Participants

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

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.20 · 95% CI 0.93 to 1.55

SecondaryNumber 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)
Reported as:: Count of participants · Participants

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

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.16 · 95% CI 0.93 to 1.45

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Preterm Premature Rupture of Membranes
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Preterm Premature Rupture of Membranes	64	46

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.30 · 95% CI 0.92 to 1.82

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Spontaneous Preterm Delivery.
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Spontaneous Preterm Delivery.	109	106

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.97 · 95% CI 0.79 to 1.19

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Indicated Preterm Delivery
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Indicated Preterm Delivery	18	14

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.21 · 95% CI 0.61 to 2.39

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Cesarean Delivery
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Cesarean Delivery	86	80

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.01 · 95% CI 0.79 to 1.31

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Chorioamnionitis
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Chorioamnionitis	18	16

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.06 · 95% CI 0.55 to 2.04

SecondaryMedian 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)
Reported as:: Median · days

Median Length of Maternal Antepartum Hospital Stay Before Delivery
days	Pessary	No Pessary
Median Length of Maternal Antepartum Hospital Stay Before Delivery	1 (0 to 1)	1 (0 to 1)

Statistical analysis

Pessary vs No Pessary · Median difference (net): 0 · 95% CI 0 to 0

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants With Vaginal Infection
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants With Vaginal Infection	57	41

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.36 · 95% CI 0.95 to 1.94

SecondaryThe 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)
Reported as:: Count of participants · Participants

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

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.45 · 95% CI 1.00 to 2.11

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Participants Treated for Preterm Labor Including Placement of Cerclage
Participants	Cervical Arabin Pessary	No Pessary
Number of Participants Treated for Preterm Labor Including Placement of Cerclage	150	143

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.02 · 95% CI 0.88 to 1.18

SecondaryMedian 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)
Reported as:: Median · days

Median Duration of Neonatal Ventilator or Continuous Positive Airway Pressure Use
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)

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Median difference (net): 0 · 95% CI -12 to 12

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates Requiring Ventilator or Continuous Positive Airway Pressure Use	75	82

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.90 · 95% CI 0.69 to 1.17

SecondaryMedian 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)
Reported as:: Median · days

Median Duration (in Days) of Neonatal Supplemental Oxygen Use
days	Cervical Arabin Pessary	No Pessary
Median Duration (in Days) of Neonatal Supplemental Oxygen Use	7 (0 to 41)	6 (0 to 51)

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Median difference (net): 1 · 95% CI -12 to 14

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Seizures Requiring Treatment
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Seizures Requiring Treatment	1	1

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.98 · 95% CI 0.06 to 15.7

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates Small for Gestational Age < 5th Percentile
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates Small for Gestational Age < 5th Percentile	5	6

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.82 · 95% CI 0.25 to 2.65

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Intraventricular Hemorrhage (IVH) Grades III or IV	4	7

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.56 · 95% CI 0.17 to 1.90

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Retinopathy of Prematurity (ROP)
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Retinopathy of Prematurity (ROP)	27	23

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.15 · 95% CI 0.68 to 1.96

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates Experiencing Respiratory Distress Syndrome (RDS)
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates Experiencing Respiratory Distress Syndrome (RDS)	67	69

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.95 · 95% CI 0.71 to 1.27

SecondaryNumber 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.
Reported as:: Count of participants · Participants

Number of Neonates With Bronchopulmonary Dysplasia (BPD)
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Bronchopulmonary Dysplasia (BPD)	14	19

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.72 · 95% CI 0.37 to 1.41

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Necrotizing Enterocolitis (NEC) Stage 2 or 3	7	6

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.14 · 95% CI 0.39 to 3.37

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Hyperbilirubinemia
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Hyperbilirubinemia	84	82

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.00 · 95% CI 0.78 to 1.29

SecondaryNeonatal 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)
Reported as:: Count of participants · Participants

Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia
Participants	Cervical Arabin Pessary	No Pessary
Neonatal Infectious Morbidity Including Sepsis, Suspected Sepsis and Pneumonia	53	65

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.80 · 95% CI 0.58 to 1.10

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Neonates With Early Onset Sepsis
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Early Onset Sepsis	5	2

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 2.45 · 95% CI 0.48 to 12.57

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Late Onset Sepsis
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Late Onset Sepsis	8	12

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.65 · 95% CI 0.27 to 1.58

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Suspected Sepsis
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Suspected Sepsis	38	51

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.67 · 95% CI 0.47 to 0.97

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Pneumonia
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Pneumonia	2	4

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 0.49 · 95% CI 0.09 to 2.66

SecondaryNumber 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)
Reported as:: Count of participants · Participants

Number of Neonates With Composite Outcome
Participants	Cervical Arabin Pessary	No Pessary
Number of Neonates With Composite Outcome	81	74

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Risk ratio (rr): 1.05 · 95% CI 0.81 to 1.37

SecondaryMedian 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)
Reported as:: Median · days

Median Length of Neonatal Hospital Stay
days	Cervical Arabin Pessary	No Pessary
Median Length of Neonatal Hospital Stay	3 (2 to 20)	3 (2 to 22)

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Median difference (net): 0 · 95% CI 0 to 0

SecondaryMedian 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)
Reported as:: Median · days

Median Number of Days in Neonatal Intensive Care Unit (NICU)
days	Cervical Arabin Pessary	No Pessary
Median Number of Days in Neonatal Intensive Care Unit (NICU)	50 (10 to 99)	37 (11 to 88)

Statistical analysis

Cervical Arabin Pessary vs No Pessary · Median difference (net): 10 · 95% CI -16 to 36

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

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

Adverse events

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.

Adverse event summary by group
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%)

Most frequent serious events

Showing 10 of 29

Most frequent serious events
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

Most frequent other events

Most frequent other events
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

Baseline characteristics

Age, Continuous
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
Sex: Female, Male(Participants)	Cervical Arabin Pessary	No Pessary	Total
Female	280	264	544
Male	0	0	0

Race/Ethnicity, Customized
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)
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)
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

Study locations

12 sites

University of Alabama - Birmingham
Birmingham, Alabama 35233, United States
Northwestern University
Chicago, Illinois 60611, United States
Columbia University
New York, New York 10032, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599, United States
Case Western Reserve University
Cleveland, Ohio 44109, United States
Ohio State University
Columbus, Ohio 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Magee Womens
Pittsburgh, Pennsylvania 15213, United States
Brown University
Providence, Rhode Island 02905, United States
University of Texas Medical Branch
Galveston, Texas 77555, United States
University of Texas - Houston
Houston, Texas 77030, United States
University of Utah
Salt Lake City, Utah 84132, United States

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Study documents

Protocol, analysis plan and consent form · Jun 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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, Sap, Icf

Registry details

Key details

Study ID: NCT02901626
Lead sponsor: The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party: Sponsor
First posted: Sep 15, 2016
Start date: Feb 14, 2017
Primary completion: Apr 2, 2022
Completion: May 10, 2022
Results posted: Jun 22, 2023
Last update: Jun 23, 2026

Study contacts

Rebecca Clifton, Ph.D.

principal investigator · George Washington University Biostatistics Center

Monica Longo, MD

study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Matthew Hoffman, MD

study chair · Christiana Care Health Services

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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

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