Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth

Study Overview
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Brief Summary
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Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) < 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination. Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage. The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC

Official Title
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Pessary as Adjunctive Therapy to Cerclage for the Prevention of 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 gestations Women with prior preterm birth and with short cervical length (TVU CL <25 mm) who underwent UIC Exclusion Criteria: multiple gestation Ruptured membranes Lethal fetal structural anomaly Fetal chromosomal abnormality 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: None (Open Label)


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). Women will receive pessary soon after UIC | Device: 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.<br>|
| No Intervention: No intervention<br>No treatment | |

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 | 
| Spontaneous 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 |