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Trendelenburg Positioning and External Cephalic Version Outcome

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ClinicalTrials.gov Identifier: NCT04585256
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breech Presentation of Fetus With Successful Version Other: Trendelenburg positioning Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Trendelenburg
Women positioned in the trendelenburg position during external cephalic version.
 Other: Trendelenburg positioning
Women positioned in the trendelenburg position prior to external cephalic version
No Intervention: Control
Women positioned on their back during external cephalic version.


Outcome Measures
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Primary Outcome Measures :
  1. External cephalic version success [ Time Frame: Up to 10 minutes from the beginning of external cephalic version. ]
    The rate of successful external cephalic version


Secondary Outcome Measures :
  1. Pain [ Time Frame: Up to 2 hours from the beginning of external cephalic version. ]
    Visual analog scale scoring from 0-10 during and following the procedure.

  2. Placental abruption [ Time Frame: Up to 1 week from the beginning of external cephalic version. ]
    Rate of clinical placental abruption

  3. Vaginal delivery [ Time Frame: Up to 4 weeks from the beginning of external cephalic version. ]
    Rate of vaginal deliveries

  4. Cesarean delivery [ Time Frame: Up to 4 weeks from the beginning of external cephalic version. ]
    Rate of cesarean deliveries


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585256


Contacts
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Contact: Roy Lauterbach, MD +972-52-9432416 r_lauterbach@rmc.gov.il

Locations
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Israel
Rambam health care campus Recruiting
Haifa, Israel
Contact: Roy Lauterbach, MD    0529432416    r_lauterbach@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam healthcare campus
More Information
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04585256    
Other Study ID Numbers: 0145-20-RMB
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications