Physical Exam Indicated Cerclage in Twin Gestations

Not Applicable

Terminated

• Conditions: Twin Pregnancy, Antepartum Condition or Complication; Cervical Dilation Premature; Preterm Birth
• Interventions: Procedure: Physical exam indicated cerclage

• Registration Number: NCT02490384
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2019-12
• Study Completion: 2019-12-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Pregnant women older than 18 years of age
2. Diamniotic twin pregnancy
3. 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

1. Singleton pregnancy or higher order than twins multiple gestation
2. Cervical dilation more than 5 cm
3. Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
4. More than 24 weeks of gestation
5. Multifetal reduction after 14 weeks
6. Monoamniotic twins
7. Twin-twin transfusion syndrome
8. Ruptured amniotic membranes at the time of diagnosis of dilated cervix
9. Major fetal structural anomaly
10. Fetal chromosomal abnormality
11. Cerclage already in place for other indications
12. Active vaginal bleeding
13. Suspicion of clinical or biochemical chorioamnionitis
14. Painful regular uterine contractions
15. Labor (progressing cervical dilation)
16. Placenta previa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical exam indicated cerclage	Physical exam indicated cerclage	Cerclage

Primary Outcome Measures

Name	Time	Method
Preterm delivery less than 34 weeks	at delivery	Incidence of preterm birth less than 34 weeks (any indication)

Secondary Outcome Measures

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

Trial Locations

Locations (11)

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Austin Maternal Fetal Medicine St David's Health Care; 🇺🇸 Austin, Texas, United States

Bologna University; 🇮🇹 Bologna, Italy

University of Brescia; 🇮🇹 Brescia, Italy

Università degli Studi di Napoli "Federico II"; 🇮🇹 Naples, Italy

Albany Medical Center; 🇺🇸 Albany, New York, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Wright State University; 🇺🇸 Dayton, Ohio, United States

University of Warsaw; 🇵🇱 Warsaw, Poland