Prevention of Preterm Birth With a Pessary in Triplet

Study Overview
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Brief Summary
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The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls. The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations. We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL <30 mm)

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 Triplet pregnancy (limits the participants to female gender) Gestational age at randomization between 20(0) and 22(6) Exclusion Criteria: Singleton, twin or higher order than triplets multiple gestation 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical Pessary<br>Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth. | Device: Cervical Pessary<br> <br> |
| No Intervention: Routine care (watch and wait)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery |  | Less than 34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery |  | Time of delivery | 
| Birth weight |  | Time of delivery | 
| pontaneous preterm birth rates |  | Less than 24, 28, 34 and 37 weeks gestation | 
| Spontaneous rupture of membranes |  | Less than 34 weeks gestation | 
| Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery |  | Time of delivery | 
| Neonatal death |  | Between birth and 28 days of age | 
| Composite adverse neonatal 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 | 
| Admission to neonatal intensive care unit |  | Between birth and 28 days of age | 
| Chorioamnionitis |  | Time of delivery | 
| Significant adverse maternal effects | Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture | Time of delivery | 
| Intolerance to pessary | Defined as request for removal secondary to discomfort and/or discharge | Prior to delivery | 
| Preterm delivery |  | Less than 24, 28 and 37 weeks |