Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

NCT ID: NCT01854450

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fetal Occipitoposterior Position During the Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Asymmetrical Lateral Decubitus

Intervention Type OTHER

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

control

usual obstetrical care

Group Type OTHER

control

Intervention Type OTHER

usual obstetrical care

Interventions

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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

Intervention Type OTHER

control

usual obstetrical care

Intervention Type OTHER

Other Intervention Names

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maternal posturing

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille Le Ray, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Port-Royal Maternity Hospital

Locations

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Maternité du CH d'Avranches-Granville

Avranches-Granville, , France

Site Status

CHU côte de nacre

Caen, , France

Site Status

Port-Royal Maternity Hospital

Paris, , France

Site Status

bluets maternity Hospital

Paris, , France

Site Status

Countries

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France

References

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Le Ray C, Lepleux F, De La Calle A, Guerin J, Sellam N, Dreyfus M, Chantry AA. Lateral asymmetric decubitus position for the rotation of occipito-posterior positions: multicenter randomized controlled trial EVADELA. Am J Obstet Gynecol. 2016 Oct;215(4):511.e1-7. doi: 10.1016/j.ajog.2016.05.033. Epub 2016 May 27.

Reference Type BACKGROUND
PMID: 27242201 (View on PubMed)

Other Identifiers

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2012-A01578-35

Identifier Type: -

Identifier Source: secondary_id

P120902

Identifier Type: -

Identifier Source: org_study_id

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