NCT04585256

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

October 6, 2020

Last Update Submit

January 21, 2023

Conditions

Breech Presentation of Fetus With Successful Version

Outcome Measures

Primary Outcomes (1)

  • External cephalic version success

    The rate of successful external cephalic version

    Up to 10 minutes from the beginning of external cephalic version.

Secondary Outcomes (4)

  • Pain

    Up to 2 hours from the beginning of external cephalic version.

  • Placental abruption

    Up to 1 week from the beginning of external cephalic version.

  • Vaginal delivery

    Up to 4 weeks from the beginning of external cephalic version.

  • Cesarean delivery

    Up to 4 weeks from the beginning of external cephalic version.

Study Arms (2)

Trendelenburg

ACTIVE COMPARATOR

Women positioned in the trendelenburg position during external cephalic version.

Other: Trendelenburg positioning

Control

NO INTERVENTION

Women positioned on their back during external cephalic version.

Interventions

Trendelenburg positioningOTHER

Women positioned in the trendelenburg position prior to external cephalic version

Trendelenburg

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Lauterbach, MD

CONTACT

+972-52-9432416r_lauterbach@rmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

November 1, 2020

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)