Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Study Overview
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Brief Summary
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Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.

Official Title
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Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Cervical pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years of age Singleton pregnancy (limits the participants to female gender) Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation Exclusion Criteria: Multiple gestation Prior spontaneous preterm birth 16-36 6/7 weeks Ruptured membranes Lethal fetal structural anomaly Fetal chromosomal abnormality Cerclage in place (or planned placement) Vaginal bleeding Suspicion of chorioamnionitis Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound Painful regular uterine contractions Placenta previa

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical Pessary<br>The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated) | Device: Cervical pessary<br>* The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)<br>|
| No Intervention: No intervention<br>No pessary No pessary will be used. Subjects will receive standard obstetrical management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth (SPTB) <34 weeks | Spontaneous preterm delivery less than 34 weeks of gestation | Less than 34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPTB <37w |  | Less than 37 weeks gestation | 
| SPTB <32w |  | Less than 32 weeks gestation | 
| SPTB <28w |  | Less than 32 weeks gestation | 
| Gestational age at delivery |  | Time of delivery | 
| Latency | interval from randomization to delivery in days | time of delivery | 
| preterm premature rupture of membranes |  | Less than 34 weeks gestation | 
| Type of delivery | Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery | time of delivery | 
| Maternal side effects | Vaginal discharge, bacterial vaginosis | Time of delivery | 
| Birth weight |  | Time of delivery | 
| Neonatal death |  | Between birth and 28 days of age | 
| perinatal death | either fetal mortality or neonatal death | fetal death after 20 weeks | 
| Composite adverse perinatal outcome | Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death | Between birth and 28 days of age | 
| Chorioamnionitis |  | Time of delivery | 
| Adminssion to neonatal intensive care unit |  | Between birth and 28 days of age |