Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Study Overview
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Brief Summary
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The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Detailed Description
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There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Official Title
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Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial

Conditions
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Twin; Pregnancy, Affecting Fetus or Newborn

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: Women pregnant in dichorionic twins. Transvaginal sonographic cervical length is <25 mm at 16-20 weeks gestational age. No symptoms, signs or other risk factors for preterm labor Exclusion Criteria: Age < 18 years or > 45 years. Known allergy or contraindication (relative or absolute) to progesterone therapy. Monochorionic twins. Known major fetal structural or chromosomal abnormality. Intrauterine death of one fetus or death of both fetuses. Fetal reduction in the current pregnancy. Medical conditions that may lead to preterm delivery. Rupture of membranes. Vaginal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: A randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cervical cerclage<br>Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm | Procedure: Cervical cerclage<br>* Cervical cerclage indicated by short cervix ≤25mm<br>* Other names: Active Comparator;|
| Active Comparator: vaginal progesterone<br>Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks | Drug: vaginal progesterone<br>* Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks<br>* Other names: Active Comparator;|
| Active Comparator: Cervical cerclage plus vaginal progesterone<br>Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks | Procedure: Cervical cerclage<br>* Cervical cerclage indicated by short cervix ≤25mm<br>* Other names: Active Comparator;Drug: vaginal progesterone<br>* Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor before 34 weeks | Number of patients with preterm birth before 34 weeks gestations | Up to 34 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal respiratory distress syndrome | number of neonatal respiratory distress syndrome | At birth | 
| Early neonatal death | number babies died in the neonatal period | within one month postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm birth, Twin gestation, Vaginal progesterone, cervical cerclage