Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

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. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.

Official Title
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Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length

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 Twin pregnancy (limits the participants to female gender) Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation Exclusion Criteria: Singleton or higher order than twins multiple gestation Monoamniotic twins Twin twin transfusion syndrome 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 Painful regular uterine contractions Labor 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


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 36th 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<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 delivery <34 weeks |  | Less than 34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age |  | Time of delivery | 
| Birth weight |  | Time of delivery | 
| Spontaneous preterm birth rates <37, <28 and <24 weeks |  | Less than 24, 28, 34 and 37 weeks gestation | 
| Spontaneous rupture of membranes | Rupture of membranes <34 weeks | Less than 34 weeks gestation | 
| Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery) | cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery | Time of delivery | 
| Neonatal death |  | Between birth and 28 days of age | 
| Composite 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 | 
| Maternal side effects |  | Maternal side effects |