Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

Not Applicable

Completed

• Conditions: Fetal Occipitoposterior Position During the Labor

• Registration Number: NCT01854450
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Primary Completion: 2015-03
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fetal head position	1 hour	fetal head position one hour after randomization

Secondary Outcome Measures

Name	Time	Method
fetal head position	at diagnosis of full dilatation	Clinical evaluation of the fetal head position at diagnosis of full cervical dilatation confirmed with ultrasound
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).
Speed of cervical dilatation	during the first stage of labour	Duration of labor between randomization and full dilatation
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

Trial Locations

Locations (4)

Maternité du CH d'Avranches-Granville; 🇫🇷 Avranches-Granville, France

CHU côte de nacre; 🇫🇷 Caen, France

Port-Royal Maternity Hospital; 🇫🇷 Paris, France

bluets maternity Hospital; 🇫🇷 Paris, France