Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02167841
Study type Interventional
Source Meir Medical Center
Contact
Status Not yet recruiting
Phase N/A
Start date June 2014
Completion date April 2016

See also
  Status Clinical Trial Phase
Recruiting NCT04579835 - Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)
Not yet recruiting NCT01922453 - Music and Sounds for ECV N/A
Completed NCT00516555 - EBIS: The Eindhoven Breech Intervention Study N/A
Completed NCT01487590 - Cephalic Version by Acupuncture-Moxibustion for Breech Presentation N/A
Completed NCT00890474 - Moxibustion for Fetus in Breech Presentation Phase 3
Terminated NCT00119184 - Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version Phase 1
Completed NCT05827627 - Simulation Techniques Used in Breech Birth Management Training N/A
Terminated NCT04538261 - Elevation of the Fetal Buttocks Prior to External Cephalic Version N/A
Recruiting NCT02801201 - Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation Phase 3
Completed NCT02331160 - Rebozo and External Cephalic Version in Breech Presentation. N/A
Completed NCT00896311 - Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women N/A
Completed NCT00901758 - Intravenous (IV) Nitroglycerin for Versions in Multiparous Women N/A
Completed NCT01048398 - Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions. Phase 3
Recruiting NCT04613778 - Correction of Breech Presentation With Laser Acupuncture N/A
Completed NCT01708018 - Effects of Relaxing Hydrotherapy in Third Trimester of Pregnancy N/A
Terminated NCT00465712 - Effect of Amnioinfusion on External Cephalic Version Successful Rate N/A
Recruiting NCT03827226 - Breech External Cephalic Version Intervention Trial
Completed NCT00813683 - Cephalic Version by Acupuncture for Breech Presentation N/A
Recruiting NCT06187948 - An Informative Video Before Planned External Cephalic Version N/A
Completed NCT00141687 - Early External Cephalic Version (ECV) 2 Trial N/A