Trendelenburg Positioning and External Cephalic Version Outcome

January 21, 2023 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

The Effect of Trendelenburg Positioning on External Cephalic Version Outcome

Women at term (over 37 weeks) that are candidates for external cephalic version will be positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure. The control group will not be positioned differently than usual. We will evaluate external cephalic version success and compare the 2 groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial that is designed to compare external cephalic version success between women positioned in the trendelenburg position 5 minutes prior to external cephalic version performance and during the procedure and a control group of women that will lie on their back without special positioning.

The women that are eligible for participation will receive a thorough explanation and will sign informed consent.

Study Type

Interventional

Enrollment (Anticipated)

180

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
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women interested in having external cephalic version at a gestational age of 37+0/7 or more.

Exclusion Criteria:

  • Age 18 and under.
  • Women with a body mass index 35 or higher.
  • Women with a previous cesarean section.
  • Women with premature rupture of membranes.
  • Women with vaginal bleeding.
  • Women with a previously failed external cephalic version.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trendelenburg
Women positioned in the trendelenburg position during external cephalic version.
Other: Trendelenburg positioning
Women positioned in the trendelenburg position prior to external cephalic version
No Intervention: Control
Women positioned on their back during external cephalic version.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External cephalic version success
Time Frame: Up to 10 minutes from the beginning of external cephalic version.
The rate of successful external cephalic version
Up to 10 minutes from the beginning of external cephalic version.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Up to 2 hours from the beginning of external cephalic version.
Visual analog scale scoring from 0-10 during and following the procedure.
Up to 2 hours from the beginning of external cephalic version.
Placental abruption
Time Frame: Up to 1 week from the beginning of external cephalic version.
Rate of clinical placental abruption
Up to 1 week from the beginning of external cephalic version.
Vaginal delivery
Time Frame: Up to 4 weeks from the beginning of external cephalic version.
Rate of vaginal deliveries
Up to 4 weeks from the beginning of external cephalic version.
Cesarean delivery
Time Frame: Up to 4 weeks from the beginning of external cephalic version.
Rate of cesarean deliveries
Up to 4 weeks from the beginning of external cephalic version.

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

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)

November 1, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0145-20-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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