Trendelenburg Positioning and External Cephalic Version Outcome

NCT ID: NCT04585256

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Breech Presentation of Fetus With Successful Version

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trendelenburg

Women positioned in the trendelenburg position during external cephalic version.

Group Type ACTIVE_COMPARATOR

Trendelenburg positioning

Intervention Type OTHER

Women positioned in the trendelenburg position prior to external cephalic version

Control

Women positioned on their back during external cephalic version.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trendelenburg positioning

Women positioned in the trendelenburg position prior to external cephalic version

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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ROY LAUTERBACH MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roy Lauterbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam healthcare campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Roy Lauterbach, MD

Role: CONTACT

+972-52-9432416

Facility Contacts

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Roy Lauterbach, MD

Role: primary

0529432416

Other Identifiers

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0145-20-RMB

Identifier Type: -

Identifier Source: org_study_id

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