Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.
Primary Purpose
Breech Presentation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Knee-Chest Position
Sponsored by
About this trial
This is an interventional treatment trial for Breech Presentation focused on measuring Breech presentation,, External cephalic version,, Maternal posture,, Pregnancy,, Caesarean section.
Eligibility Criteria
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.
Sites / Locations
- Meir Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Knee-Chest position
External Cephalic Version
Arm Description
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)
In this group the women will perform External Cephalic Version without doing maternal Knee-Chest position before.
Outcomes
Primary Outcome Measures
number of participants
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02167841
Brief Title
Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
Breech presentation,, External cephalic version,, Maternal posture,, Pregnancy,, Caesarean section.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee-Chest position
Arm Type
Experimental
Arm Description
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)
Arm Title
External Cephalic Version
Arm Type
No Intervention
Arm Description
In this group the women will perform External Cephalic Version without doing maternal Knee-Chest position before.
Intervention Type
Behavioral
Intervention Name(s)
Knee-Chest Position
Primary Outcome Measure Information:
Title
number of participants
Time Frame
up to 5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Meir Hospital
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.
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