Clinical trial NCT01854450: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position
Official title: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Occipitoposterior Position During the Labor
Keywords: Occipitoposterior position
Maternal posturing
Labor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 326
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fetal head position
timeFrame: 1 hour
Secondary outcomes:
measure: fetal head position
timeFrame: at diagnosis of full dilatation
measure: Speed of cervical dilatation
timeFrame: during the first stage of labour
measure: Mode of delivery and perineal complications
timeFrame: at delivery
measure: feasibility and acceptability of asymmetrical lateral decubitus
timeFrame: during and after labour
Other outcomes:
Locations:
city: Avranches-Granville
country: France
facility: Maternité du CH d'Avranches-Granville
city: Caen
country: France
facility: CHU côte de nacre
city: Paris
country: France
facility: Port-Royal Maternity Hospital
city: Paris
country: France
facility: bluets maternity Hospital
Study officials:
affiliation: Port-Royal Maternity Hospital
name: Camille Le Ray, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: