Comparison of Efficiency Between Practicing of Knee Chest Position and External Cephalic Version in Cases of Breech Presentation.

Breech Presentation Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02167841
• Other study ID #: 0265-13-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 19, 2014
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2014
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Behavioral:
• Knee-Chest Position

Locations

Country	Name	City	State
Israel	Meir Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants		up to 5 weeks	No