Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Study Overview
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Brief Summary
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Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size

Official Title
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Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Procedure: Cervical cerclage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy (limits the participants to female gender) Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation 18-50 years of age Exclusion Criteria: Multiple gestation Prior spontaneous preterm birth 16-36 6/7 weeks Ruptured membranes Lethal fetal structural anomaly Fetal chromosomal abnormality Pessary 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical cerclage<br>Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix | Procedure: Cervical cerclage<br>* Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)<br>|
| No Intervention: No intervention<br>No cerclage Women randomized to not receive cerclage represent the control arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth rates <34weeks |  | Less than 34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth rates <37, <28 and <24 weeks |  | Less than 24, 28, and 37 weeks gestation | 
| Type of delivery | Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery | Time of delivery | 
| Spontaneous rupture of membranes | Ruptured membranes <34 weeks | Less than 34 weeks gestation | 
| Neonatal death |  | Between birth and 28 days of age | 
| birth weight |  | Time of delivery | 
| Chorioamnionitis | histologic diagnosis of chorioamnionitis | Time of delivery | 
| necrotizing enterocolitis |  | Between birth and 28 days of age | 
| intraventricular hemorrhage | intraventricular hemorrhage (grade 3 or higher) | Between birth and 28 days of age | 
| respiratory distress syndrome |  | Between birth and 28 days of age | 
| bronchopulmonary dysplasia |  | Between birth and 28 days of age | 
| blood-culture proven sepsis |  | Between birth and 28 days of age | 
| neonatal mortality | death of a live-born baby within the first 28 days of life | Between birth and 28 days of age | 
| perinatal death | either fetal mortality or neonatal mortality | Until 28 days of age |