CClinicalTrials.gg
Status unknownNCT04585256Updated Jan 25, 2023

Trendelenburg Positioning and External Cephalic Version Outcome

An interventional study of Trendelenburg positioning in Breech Presentation of Fetus With Successful Version, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breech Presentation of Fetus With Successful Version

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Trendelenburg

    Women positioned in the trendelenburg position during external cephalic version.

    Other: Trendelenburg positioning

  • No intervention
    Control

    Women positioned on their back during external cephalic version.

Interventions

  • OtherTrendelenburg positioning

    Women positioned in the trendelenburg position prior to external cephalic version

05

What researchers measure

Primary outcomes

  1. External cephalic version success

    The rate of successful external cephalic version

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

Secondary outcomes

  1. Pain

    Visual analog scale scoring from 0-10 during and following the procedure.

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

  2. Placental abruption

    Rate of clinical placental abruption

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

  3. Vaginal delivery

    Rate of vaginal deliveries

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

  4. Cesarean delivery

    Rate of cesarean deliveries

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04585256
Lead sponsor
Rambam Health Care Campus
Responsible party
ROY LAUTERBACH MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Oct 14, 2020
Start date
Nov 1, 2020
Primary completion
Sep 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jan 25, 2023

Study contacts

Roy Lauterbach, MD
Contact
r_lauterbach@rmc.gov.il
+972-52-9432416
Roy Lauterbach, MD
principal investigator · Rambam healthcare campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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