Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position (EVADELA)

August 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial

Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.

Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of fetal occipitoposterior position during labor is 20%. Compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration).

Maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. Asymmetrical lateral decubitus is used frequently, without having ever been evaluated.

Our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial.

We hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.

Study Type

Interventional

Enrollment (Actual)

326

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

  • France
      • Avranches-Granville, France
        • Maternité du CH d'Avranches-Granville
      • Caen, France
        • CHU Côte de Nacre
      • Paris, France, 75005
        • Port-Royal Maternity Hospital
      • Paris, France
        • bluets maternity Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • women older than 18 years
  • Gestational age ≥ 37SA,
  • Ruptured membranes,
  • single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound.
  • Affiliation to a social security scheme (beneficiary or assignee)
  • Signing the consent

Exclusion Criteria:

  • Fetal presentation other than posterior
  • Multiple pregnancy,
  • Breech presentation
  • History of previous cesarean section
  • Fetal death in utero, termination of pregnancy
  • Fetal intrauterine fetal growth restriction <5e percentile,
  • Fetal malformation,
  • Women younger than 18 years old,
  • Women do not understand French,
  • Women with psychiatric condition

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: Asymmetrical Lateral Decubitus
Women in labor are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion
Other: Asymmetrical Lateral Decubitus

After randomization, women are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion, during 1 hour (minimum 30 minutes).

Then, women are encouraged to take this posture during labor as frequently as possible if the fetus remains in occipitoposterior position

Other Names:
  • maternal posturing
Other: control
usual obstetrical care
Other: control
usual obstetrical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal head position
Time Frame: 1 hour
fetal head position one hour after randomization
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetal head position
Time Frame: at diagnosis of full dilatation
Clinical evaluation of the fetal head position at diagnosis of full cervical dilatation confirmed with ultrasound
at diagnosis of full dilatation
Speed of cervical dilatation
Time Frame: during the first stage of labour
Duration of labor between randomization and full dilatation
during the first stage of labour
Mode of delivery and perineal complications
Time Frame: at delivery
Mode of delivery (spontaneous vaginal, instrumental vaginal delivery, cesarean section) and perineal complications (episiotomy, severe perineal tears).
at delivery
feasibility and acceptability of asymmetrical lateral decubitus
Time Frame: during and after labour
quality of fetal heart rate monitoring during maternal posturing Evaluation of maternal satisfaction using self-administered questionnaire
during and after labour

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Principal Investigator: Camille Le Ray, MD, PhD, Port-Royal Maternity Hospital

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

May 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimated)

May 15, 2013

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P120902
  • 2012-A01578-35

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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