Physical Exam Indicated Cerclage in Twin Gestations

Study Overview
=================
Brief Summary
-----------------
This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.

Detailed Description
-----------------
Twin pregnancies have 58% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.

Official Title
-----------------
Randomized Control Trial Physical Exam Indicated Cerclage in Twin Gestations

Conditions
-----------------
Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation Premature

Intervention / Treatment
-----------------
* Procedure: Physical exam indicated cerclage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women older than 18 years of age Diamniotic twin pregnancy Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation Exclusion Criteria: Singleton pregnancy or higher order than twins multiple gestation Cervical dilation more than 5 cm Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue More than 24 weeks of gestation Multifetal reduction after 14 weeks Monoamniotic twins Twin-twin transfusion syndrome Ruptured amniotic membranes at the time of diagnosis of dilated cervix Major fetal structural anomaly Fetal chromosomal abnormality Cerclage already in place for other indications Active vaginal bleeding Suspicion of clinical or biochemical chorioamnionitis Painful regular uterine contractions Labor (progressing cervical dilation) Placenta previa

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical exam indicated cerclage<br>Cerclage | Procedure: Physical exam indicated cerclage<br>* Cervical cerclage<br>|
| No Intervention: Expectant management<br>No cerclage | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery less than 34 weeks | Incidence of preterm birth less than 34 weeks (any indication) | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth less than 34 | Incidence of spontaneous preterm birth less than 34 weeks | at delivery | 
| Preterm delivery less than <32 weeks, <28 weeks, or <24 weeks | Incidence of preterm birth less than <32 weeks, <28 weeks, or <24 weeks | at delivery | 
| Mean gestational age at delivery | Mean value of gestational age at delivery (weeks) | at delivery | 
| Birth weight at birth | Mean value (grams) | at delivery | 
| Gestational age at spontaneous rupture of membranes | Mean value (weeks) through study completion | at presentation of rupture membranes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cerclage