Physical Exam Indicated Cerclage in Twin Gestations

NCT ID: NCT02490384

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-12-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical exam indicated cerclage

Cerclage

Group Type: ACTIVE_COMPARATOR

Physical exam indicated cerclage

Intervention Type: PROCEDURE

Cervical cerclage

Expectant management

No cerclage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical exam indicated cerclage

Cervical cerclage

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: collaborator

Albany Medical College

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

Wright State University

OTHER

Sponsor Role: collaborator

Baystate Medical Center

OTHER

Sponsor Role: collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University of Warsaw

OTHER

Sponsor Role: collaborator

Maternal Fetal Medicine Associates

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Roman, MD

Role: PRINCIPAL_INVESTIGATOR

amanda.roman@jefferson.edu

Locations

George Washington University

Washington D.C., District of Columbia, United States

Albany Medical Center

Albany, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Wright State University

Dayton, Ohio, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 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

University of Warsaw

Warsaw, , Poland

Countries

United States; Italy; Poland

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ThomasJeffersonU

Identifier Type: -

Identifier Source: org_study_id