Physical Exam Indicated Cerclage in Twin Gestations

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.

Conditions

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

Interventions

PROCEDURE

Physical exam indicated cerclage

Cervical cerclage

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Albany Medical College

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• George Washington University

  collaborator OTHER

• Wright State University

  collaborator OTHER

• Baystate Medical Center

  collaborator OTHER

• Università degli Studi di Brescia

  collaborator OTHER

• University of Bologna

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University of Warsaw

  collaborator OTHER

• Maternal Fetal Medicine Associates

  collaborator OTHER

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Amanda Roman, MD · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2019-12-31

Completion

2019-12-12

Countries

• United States
• Italy
• Poland

Study Locations