Back to resultsTrendelenburg Positioning and External Cephalic Version Outcome
Primary Purpose
Breech Presentation of Fetus With Successful Version
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Trendelenburg positioning
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation of Fetus With Successful Version
Eligibility 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.
Sites / Locations
- Rambam health care campusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Trendelenburg
Control
Arm Description
Women positioned in the trendelenburg position during external cephalic version.
Women positioned on their back during external cephalic version.
Outcomes
Primary Outcome Measures
External cephalic version success
The rate of successful external cephalic version
Secondary Outcome Measures
Pain
Visual analog scale scoring from 0-10 during and following the procedure.
Placental abruption
Rate of clinical placental abruption
Vaginal delivery
Rate of vaginal deliveries
Cesarean delivery
Rate of cesarean deliveries
Full Information
NCT ID
NCT04585256
First Posted
October 6, 2020
Last Updated
January 21, 2023
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04585256
Brief Title
Trendelenburg Positioning and External Cephalic Version Outcome
Official Title
The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation of Fetus With Successful Version
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trendelenburg
Arm Type
Active Comparator
Arm Description
Women positioned in the trendelenburg position during external cephalic version.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Women positioned on their back during external cephalic version.
Intervention Type
Other
Intervention Name(s)
Trendelenburg positioning
Intervention Description
Women positioned in the trendelenburg position prior to external cephalic version
Primary Outcome Measure Information:
Title
External cephalic version success
Description
The rate of successful external cephalic version
Time Frame
Up to 10 minutes from the beginning of external cephalic version.
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Title
Placental abruption
Description
Rate of clinical placental abruption
Time Frame
Up to 1 week from the beginning of external cephalic version.
Title
Vaginal delivery
Description
Rate of vaginal deliveries
Time Frame
Up to 4 weeks from the beginning of external cephalic version.
Title
Cesarean delivery
Description
Rate of cesarean deliveries
Time Frame
Up to 4 weeks from the beginning of external cephalic version.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roy Lauterbach, MD
Phone
+972-52-9432416
Email
r_lauterbach@rmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam healthcare campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Phone
0529432416
Email
r_lauterbach@rambam.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trendelenburg Positioning and External Cephalic Version Outcome
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