Trendelenburg Positioning and External Cephalic Version Outcome

Not Applicable

Recruiting

• Conditions: Breech Presentation of Fetus With Successful Version
• Interventions: Other: Trendelenburg positioning

• Registration Number: NCT04585256
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2020-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-21
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trendelenburg	Trendelenburg positioning	Women positioned in the trendelenburg position during external cephalic version.

Primary Outcome Measures

Name	Time	Method
External cephalic version success	Up to 10 minutes from the beginning of external cephalic version.	The rate of successful external cephalic version

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel