External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin

April 17, 2024 updated by: Zvi Ehrlich, Shaare Zedek Medical Center
In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
          • Zvi Ehrlich, MD
        • Principal Investigator:
          • Zvi Ehrlich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or older multiparous no previous cesarean delivery (CD) a non-vertex presenting twin in a term (37 weeks gestation and onwards) dichorionic diamniotic twin pregnancy

Exclusion Criteria:

  • contraindication for a vaginal delivery nulliparous monochorionic diamniotic pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Procedure: External cephalic version
An ECV attempt is made on the study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rates of ECV
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal and fetal morbidities
Time Frame: up to 7 days from enrollment
up to 7 days from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0327-21-SZMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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