Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (<=25mm) and without prior spontaneous preterm birth

Detailed Description
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Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth <35 weeks

Official Title
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Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Cervical cerclage
* Drug: Vaginal progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 year old or older Singleton pregnancy No prior SPTB or second trimester losses between 160 and 366 weeks TVU CL ≤25mm between 180 and 236 weeks Exclusion Criteria: Multiple pregnancy Prior SPTB or second trimester losses between 160 and 366 weeks Cerclage in situ Painful regular uterine contraction and/or preterm labor Rupture membranes Major fetal anomaly or aneuploidy Active vaginal bleeding Placenta previa and/or accreta Cervical dilation >1.0 cm and/or visible membranes by pelvic exam Suspicion of chorioamnionitis

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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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerclage<br>Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. | Procedure: Cervical cerclage<br>* Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks<br>Drug: Vaginal progesterone<br>* Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks<br>|
| Other: Control<br>Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks. | Drug: Vaginal progesterone<br>* Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth <35 weeks | Incidence of spontaneous preterm birth less than 35 weeks | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks |  | At delivery | 
| Mean gestational age at delivery |  | At delivery | 
| Histologically proven clinical chorioamnionitis |  | At delivery | 
| Neonatal outcomes: birth weight |  | At delivery | 
| Neonatal outcomes: low birth weight (<2500g), |  | At delivery | 
| Neonatal outcomes: admission to intensive care nursery |  | At delivery | 
| Neonatal outcomes: length of neonatal hospital admission |  | at least 30 days after delivery, up to 6 months after delivery | 
| Neonatal outcomes: respiratory distress syndrome |  | at least 30 days after delivery, up to 6 months after delivery | 
| Neonatal outcomes: IVH grade 3 or 4 |  | at least 30 days after delivery, up to 6 months after delivery | 
| Neonatal outcomes: retinopathy of prematurity |  | at least 30 days after delivery, up to 6 months after delivery | 
| Neonatal outcomes: bronchopulmonary dysplasia |  | at least 30 days after delivery, up to 6 months after delivery | 
| Neonatal outcomes: neonatal mortality |  | 28 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerclage, preterm birth, short cervix