NCT01854450

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

May 13, 2013

Last Update Submit

August 29, 2025

Conditions

Fetal Occipitoposterior Position During the Labor

Keywords

Occipitoposterior positionMaternal posturingLabor

Outcome Measures

Primary Outcomes (1)

  • Fetal head position

    fetal head position one hour after randomization

    1 hour

Secondary Outcomes (4)

  • fetal head position

    at diagnosis of full dilatation

  • Speed of cervical dilatation

    during the first stage of labour

  • Mode of delivery and perineal complications

    at delivery

  • feasibility and acceptability of asymmetrical lateral decubitus

    during and after labour

Study Arms (2)

Asymmetrical Lateral Decubitus

EXPERIMENTAL

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

control

OTHER

usual obstetrical care

Other: control

Interventions

Asymmetrical Lateral DecubitusOTHER

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

Also known as: maternal posturing
Asymmetrical Lateral Decubitus
controlOTHER

usual obstetrical care

control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maternité du CH d'Avranches-Granville

Avranches-Granville, France

Location

CHU côte de nacre

Caen, France

Location

Port-Royal Maternity Hospital

Paris, 75005, France

Location

bluets maternity Hospital

Paris, France

Location

Related Publications (1)

  • 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.

    PMID: 27242201BACKGROUND

Study Officials

  • Camille Le Ray, MD, PhD

    Port-Royal Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 15, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations

FR(4)