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

Primary Purpose

Fetal Occipitoposterior Position During the Labor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Asymmetrical Lateral Decubitus
control
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Occipitoposterior Position During the Labor focused on measuring Occipitoposterior position, Maternal posturing, Labor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maternité du CH d'Avranches-Granville
  • CHU côte de nacre
  • Port-Royal Maternity Hospital
  • bluets maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Asymmetrical Lateral Decubitus

control

Arm Description

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

usual obstetrical care

Outcomes

Primary Outcome Measures

Fetal head position
fetal head position one hour after randomization

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2013
Last Updated
May 19, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01854450
Brief Title
Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position
Acronym
EVADELA
Official Title
Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Occipitoposterior Position During the Labor
Keywords
Occipitoposterior position, Maternal posturing, Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asymmetrical Lateral Decubitus
Arm Type
Experimental
Arm Description
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
Arm Title
control
Arm Type
Other
Arm Description
usual obstetrical care
Intervention Type
Other
Intervention Name(s)
Asymmetrical Lateral Decubitus
Other Intervention Name(s)
maternal posturing
Intervention Description
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
Intervention Name(s)
control
Intervention Description
usual obstetrical care
Primary Outcome Measure Information:
Title
Fetal head position
Description
fetal head position one hour after randomization
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
fetal head position
Description
Clinical evaluation of the fetal head position at diagnosis of full cervical dilatation confirmed with ultrasound
Time Frame
at diagnosis of full dilatation
Title
Speed of cervical dilatation
Description
Duration of labor between randomization and full dilatation
Time Frame
during the first stage of labour
Title
Mode of delivery and perineal complications
Description
Mode of delivery (spontaneous vaginal, instrumental vaginal delivery, cesarean section) and perineal complications (episiotomy, severe perineal tears).
Time Frame
at delivery
Title
feasibility and acceptability of asymmetrical lateral decubitus
Description
quality of fetal heart rate monitoring during maternal posturing Evaluation of maternal satisfaction using self-administered questionnaire
Time Frame
during and after labour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Le Ray, MD, PhD
Organizational Affiliation
Port-Royal Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternité du CH d'Avranches-Granville
City
Avranches-Granville
Country
France
Facility Name
CHU côte de nacre
City
Caen
Country
France
Facility Name
Port-Royal Maternity Hospital
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
bluets maternity Hospital
City
Paris
Country
France

12. IPD Sharing Statement

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Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

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