- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02167841
Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.
Background: The incidence of breech presentation in pregnant women is 4%. The situation can be treated by two methods. The first is a version of the fetus from breech presentation to head presentation, which can be performed in several ways, such as, an action called EXTERNAL CEPHALIC VERSION as well as the Knee-Chest position by the pregnant mother and the second is a cesarean section. In this study we wish to investigate if the Knee-Chest position is as effective as the ECV action and as a result to decrease the need for ECV.
Hypotheses: According to our assumption, the Knee-Chest position can reduce the need for the ECV action.
Objectives: Investigate whether daily Knee-Chest position is as effective as ECV.
Methods: The investigators will conduct a "randomized clinical trial" study. Every pregnant woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned into one of two groups. In the first group the women will perform daily the Knee-Chest position between weeks 32-37. In week 37 the investigators will check via ultra sound if there was a successful version (if not, the woman would go to ECV) in the second group we will perform ECV without doing maternal Knee-Chest position before. Every woman will fill a questionnaire which includes gynecological history and details regarding the degree of persistence and performance of the activity. At the end of this process the investigators will analyze the results and will come to the conclusions.
Significance: With ECV there are number of risks and complications such as fetal distress, placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus. The frequency of these complications is 1%-2%. If it is discovered that the Knee-Chest position is effective as the ECV action, the investigators will recommend every patient to persist with this position and avoid the ECV action and the risks it entails.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kfar Saba, Israel
- Meir Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Pregnant woman in a breech presentation with a singleton between weeks 28-32.
Exclusion Criteria:
- Antepartum Hemorrhage.
- Premature rupture of membranes.
- Placenta Previa.
- Oligohydramnios.
- Twin Pregnancy.
- Uterine malformation.
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 |
---|---|
Experimental: Knee-Chest position
In this arm, the women will perform daily the Knee-Chest position between weeks 32-37.
In week 37 the investigators will check via ultra sound if there was a successful version (if not, the woman would go to External Cephalic Version)
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No Intervention: External Cephalic Version
In this group the women will perform External Cephalic Version without doing maternal Knee-Chest position before.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants
Time Frame: up to 5 weeks
|
up to 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0265-13-MMC
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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