Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate

Last updated: February 14, 2024
Sponsor: Hospital St. Joseph, Marseille, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transperineal ultrasound measurements of AOP

Clinical Study ID

NCT05779735
2022-A01978-35 DELIVERY
  • Ages > 18
  • Female

Study Summary

Ultrasound during labor and measurement of Angle of progression showed extensive prospective and retrospective publications since 2010. The investigators performed between 2013 and 2016 the only one multicenter, randomized controlled Trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. The investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position This randomised PILOT study showed that measurement of Angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018.

The objective of this new study is therefore to validate the results of this PILOT study in a more powerful multicenter randomized trial (DELIVERY).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nulliparous or multiparous women with no history of vaginal delivery,
  • > or = 37 weeks amenorrhoea
  • Cephalic presentation in anterior position (occipito-pubic position, left anterioroccipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound
  • uncertain fetal head engagement on digital examination or midline fetal presentationin prolonged second stage of labor (at least 2 hours),

Exclusion

Exclusion Criteria:

  • Multiparous women who were previous vaginal deliveries,
  • Presentation other than cephalic,
  • Twin pregnancies,
  • Posterior or transverse position
  • Transperineal ultrasound for head-perineum distance measurement
  • Fetal heart rate abnormalities requiring rapid delivery,
  • Contraindication to vaginal delivery whether maternal or fetal

Study Design

Total Participants: 182
Treatment Group(s): 1
Primary Treatment: Transperineal ultrasound measurements of AOP
Phase:
Study Start date:
September 13, 2023
Estimated Completion Date:
October 13, 2025

Connect with a study center

  • CHU de Lille - Hôpital Jeanne de Flandre

    Lille, 59000
    France

    Active - Recruiting

  • APHM Hôpital Conception

    Marseille, 13005
    France

    Active - Recruiting

  • APHM Hôpital Nord

    Marseille, 13015
    France

    Active - Recruiting

  • Hopital Saint Joseph

    Marseille, 13008
    France

    Active - Recruiting

  • Hôpital Armand Trousseau AP-HP

    Paris, 75012
    France

    Active - Recruiting

  • CHIC Poissy

    Poissy, 78300
    France

    Active - Recruiting

  • CHITS Hôpital Sainte Musse

    Toulon, 83000
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.