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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Fetal Occipitoposterior Position During the Labor

Treatments

Other: control
Other: Asymmetrical Lateral Decubitus

Study type

Interventional

Funder types

Other

Identifiers

NCT01854450
2012-A01578-35
P120902

Details and patient eligibility

About

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.

Full 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.

Enrollment

326 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

326 participants in 2 patient groups

Asymmetrical Lateral Decubitus
Experimental group
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
Treatment:
Other: Asymmetrical Lateral Decubitus
control
Other group
Description:
usual obstetrical care
Treatment:
Other: control

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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