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EVADELA: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01854450
Collaborator
(none)
326
Enrollment
4
Locations
2
Arms
24
Duration (Months)
81.5
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Asymmetrical Lateral Decubitus
  • Other: control
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
326 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Fetal head position [1 hour]

      fetal head position one hour after randomization

    Secondary Outcome Measures

    1. fetal head position [at diagnosis of full dilatation]

      Clinical evaluation of the fetal head position at diagnosis of full cervical dilatation confirmed with ultrasound

    2. Speed of cervical dilatation [during the first stage of labour]

      Duration of labor between randomization and full dilatation

    3. Mode of delivery and perineal complications [at delivery]

      Mode of delivery (spontaneous vaginal, instrumental vaginal delivery, cesarean section) and perineal complications (episiotomy, severe perineal tears).

    4. feasibility and acceptability of asymmetrical lateral decubitus [during and after labour]

      quality of fetal heart rate monitoring during maternal posturing Evaluation of maternal satisfaction using self-administered questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternité du CH d'Avranches-Granville Avranches-Granville France
    2 CHU côte de nacre Caen France
    3 Port-Royal Maternity Hospital Paris France 75005
    4 bluets maternity Hospital Paris France

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT01854450
    Other Study ID Numbers:
    • P120902
    • 2012-A01578-35
    First Posted:
    May 15, 2013
    Last Update Posted:
    May 20, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Occipitoposterior position
    Maternal posturing
    Labor
    Additional relevant MeSH terms:
    Pressure Ulcer

    Study Results

    No Results Posted as of May 20, 2015