Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation

Study Overview
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Brief Summary
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RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).

Official Title
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Randomized Controlled Trial: Physical Exam Indicated Cerclage in Singleton Gestation 24 Weeks to 25 Weeks and 6 Days Gestation

Conditions
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Preterm Birth

Intervention / Treatment
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* Procedure: Physical Exam Indicated Cerclage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women 18 years of age or older Nulliparous patient, has not had a preterm to term delivery Singleton pregnancy English or Spanish speaking Asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation Exclusion Criteria: Twin or higher order multi-fetal gestation Multiparous patient, has had one or more preterm to term deliveries Cervical dilation more than 2 cm either at the beginning of the study or any time during the study Amniotic membranes prolapsed beyond the external os Fetal reduction procedure performed during current pregnancy Ruptured membranes prior to randomization Major fetal structural anomaly Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing Cerclage already in place for other indication Active vaginal bleeding Suspicion of chorioamnionitis Placenta previa Painful regular uterine contractions History of preterm birth before 37 weeks gestation Non-English or non-Spanish speaking a. Given that the study is explained in person and consent forms are written in English, there is no guarantee that the study will be explained correctly when using a phone translator. The same is true if the current English consent form were to be translated into a language other than English. There is no way to confirm that the integrity of the study is being upheld by using translating services. If the integrity of the study is not upheld, then this poses harm to the patient. Women under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerclage<br>Perform physical exam indicated cerclage between 24w0d to 25w6d | Procedure: Physical Exam Indicated Cerclage<br>* Transvaginal cervical cerclage<br>|
| No Intervention: Control<br>No intervention; routine monitoring in pregnancy for preterm delivery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm Delivery Rate | Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Outcomes | Rate of neonatal outcomes compared between the two groups ( NICU length of stay, neonatal death, neonatal disease (bronchopulmonary dysplasia, Necrotizing enterocolitis, Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy of prematurity, sepsis, death) | 1 Year |