- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04585256
Trendelenburg Positioning and External Cephalic Version Outcome
The Effect of Trendelenburg Positioning on External Cephalic Version Outcome
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roy Lauterbach, MD
- Phone Number: +972-52-9432416
- Email: r_lauterbach@rmc.gov.il
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Rambam Health Care Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Trendelenburg
Women positioned in the trendelenburg position during external cephalic version.
|
Women positioned in the trendelenburg position prior to external cephalic version
|
No Intervention: Control
Women positioned on their back during external cephalic version.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
External cephalic version success
Time Frame: Up to 10 minutes from the beginning of external cephalic version.
|
The rate of successful external cephalic version
|
Up to 10 minutes from the beginning of external cephalic version.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 hours from the beginning of external cephalic version.
|
Placental abruption
Time Frame: Up to 1 week from the beginning of external cephalic version.
|
Rate of clinical placental abruption
|
Up to 1 week from the beginning of external cephalic version.
|
Vaginal delivery
Time Frame: Up to 4 weeks from the beginning of external cephalic version.
|
Rate of vaginal deliveries
|
Up to 4 weeks from the beginning of external cephalic version.
|
Cesarean delivery
Time Frame: Up to 4 weeks from the beginning of external cephalic version.
|
Rate of cesarean deliveries
|
Up to 4 weeks from the beginning of external cephalic version.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0145-20-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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