Maternal Positioning and Occipitoposterior Fetal Position

November 11, 2014 updated by: Marie-Julia GUITTIER, University Hospital, Geneva

Maternal Positioning to Correct Occipitoposterior Fetal Position in Labor: A Randomized Controlled Trial

The aim of the study is to evaluate the efficacy of a specific maternal position to correct fetal position in occipito-posterior during the labor.

The investigators hypothesize that the maternal position described by the Dr de Gasquet facilitate the rotation in occipito-anterior during the labor.

The calculated sample size is 438 participants (219 in each group)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial

Study Type

Interventional

Enrollment (Actual)

438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Maternity of University Hospitals
      • Geneva, Switzerland, 1211
        • University Hospitals - Maternity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton
  • primiparous and multiparous
  • Term ≥ 37 weeks
  • Labor in dilatation phase (cervix effaced, permeable finger 2 to 9 cm)
  • Diagnosis of occipitoposterior variety confirmed by ultrasound

Exclusion Criteria:

  • Maternal age below 18 years old
  • Misunderstanding the French Language
  • Full dilatation of the cervix
  • Posture evaluated already adopted by the woman during labor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Specific maternal position
women allocated to intervention group will be invited to adopt a posture all fours type:"support on the knees, torso tilted forward, back stretched" for a minimum of 10 minutes. A cushion is placed between the legs of the woman to limit the cuts. According to Dr de Gasquet, author of the description of this posture, the effect on the variety of presentation would be almost immediate.
Other: Specific maternal position during the labor
women allocated to intervention group will be invited to adopt a posture all fours type:"support on the knees, torso tilted forward, back stretched" for a minimum of 10 minutes. A cushion is placed between the legs of the woman to limit the cuts.
No Intervention: Control
Not specific intervention for this group- Only usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal presentation after the intervention compare to control group
Time Frame: One hour after the randomization for the study
Diagnosis of the fetal presentation will be measured by an ultra-sound one hour after the randomization in both groups: intervention and control
One hour after the randomization for the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal comfort and pain sensation
Time Frame: During the hour after the randomization
Auto-administrated questionnaire to assess comfort of the maternal position and pain related to the labor, in intervention group and control group
During the hour after the randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Swiss National Science Foundation
University of Applied Sciences of Western Switzerland

Investigators

  • Principal Investigator: Marie-Julia GUITTIER, PhD, University Hospitals of Geneva-Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER10-042

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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