Trendelenburg Positioning and External Cephalic Version Outcome

Breech Presentation of Fetus With Successful Version Clinical Trial

Official title:

The Effect of Trendelenburg Positioning on External Cephalic Version Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585256
• Other study ID #: 0145-20-RMB
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Rambam Health Care Campus
• Contact: Roy Lauterbach, MD
• Phone: +972-52-9432416
• Email: r_lauterbach[@]rmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breech Presentation
• Breech Presentation of Fetus With Successful Version

Intervention

Other:
• Trendelenburg positioning
Women positioned in the trendelenburg position prior to external cephalic version

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	External cephalic version success	The rate of successful external cephalic version	Up to 10 minutes from the beginning of external cephalic version.
Secondary	Pain	Visual analog scale scoring from 0-10 during and following the procedure.	Up to 2 hours from the beginning of external cephalic version.
Secondary	Placental abruption	Rate of clinical placental abruption	Up to 1 week from the beginning of external cephalic version.
Secondary	Vaginal delivery	Rate of vaginal deliveries	Up to 4 weeks from the beginning of external cephalic version.
Secondary	Cesarean delivery	Rate of cesarean deliveries	Up to 4 weeks from the beginning of external cephalic version.