An interventional study of Knee-Chest Position in Breech Presentation, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-20.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 100 is below the median of 119 across 31 interventional studies indexed under Breech Presentation.
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Pregnant woman in a breech presentation with a singleton between weeks 28-32.
Exclusion Criteria:
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)
Behavioral: Knee-Chest Position
In this group the women will perform External Cephalic Version without doing maternal Knee-Chest position before.
number of participants
Time frame: up to 5 weeks
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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