Breech Presentation of Fetus With Successful Version
Conditions
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.
Interventions
OTHERTrendelenburg positioning
Women positioned in the trendelenburg position prior to external cephalic version
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| External cephalic version success | Up to 10 minutes from the beginning of external cephalic version. | The rate of successful external cephalic version |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Up to 2 hours from the beginning of external cephalic version. | Visual analog scale scoring from 0-10 during and following the procedure. |
| Placental abruption | Up to 1 week from the beginning of external cephalic version. | Rate of clinical placental abruption |
| Vaginal delivery | Up to 4 weeks from the beginning of external cephalic version. | Rate of vaginal deliveries |
| Cesarean delivery | Up to 4 weeks from the beginning of external cephalic version. | Rate of cesarean deliveries |
Countries
Israel
Contacts
Primary ContactRoy Lauterbach, MD
Outcome results
None listed