Trendelenburg Positioning and External Cephalic Version Outcome

Rambam Health Care Campus

Status: Enrolling

Conditions: Breech Presentation of Fetus With Successful Version

Treatments: Other: Trendelenburg positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT04585256

0145-20-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Trendelenburg

Active Comparator group

Description:

Women positioned in the trendelenburg position during external cephalic version.

Treatment:

Other: Trendelenburg positioning

Control

No Intervention group

Description:

Women positioned on their back during external cephalic version.