Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

Study Overview
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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.

Official Title
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Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial

Conditions
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Fetal Occipitoposterior Position During the Labor

Intervention / Treatment
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* Other: Asymmetrical Lateral Decubitus
* Other: control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asymmetrical Lateral Decubitus<br>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<br>* 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<br>* Other names: maternal posturing;|
| Other: control<br>usual obstetrical care | Other: control<br>* usual obstetrical care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal head position | fetal head position one hour after randomization | 1 hour | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occipitoposterior position, Maternal posturing, Labor