Trendelenburg Positioning and External Cephalic Version Outcome

Study Overview
=================
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.

Official Title
-----------------
The Effect of Trendelenburg Positioning on External Cephalic Version Outcome

Conditions
-----------------
Breech Presentation of Fetus With Successful Version

Intervention / Treatment
-----------------
* Other: Trendelenburg positioning


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trendelenburg<br>Women positioned in the trendelenburg position during external cephalic version. | Other: Trendelenburg positioning<br>* Women positioned in the trendelenburg position prior to external cephalic version<br>|
| No Intervention: Control<br>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 | 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 | 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 | Rate of clinical placental abruption | Up to 1 week from the beginning of external cephalic version. | 
| Vaginal delivery | Rate of vaginal deliveries | Up to 4 weeks from the beginning of external cephalic version. | 
| Cesarean delivery | Rate of cesarean deliveries | Up to 4 weeks from the beginning of external cephalic version. |