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

NCT05779735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-02-15

No results posted yet for this 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).

Conditions

  • Prolonged Second Stage of Labor

Interventions

DIAGNOSTIC_TEST

Transperineal ultrasound measurements of AOP

The angle of progression (AOP) defined as the angle between the pubic bone axis and the leading part of the fetal head

Sponsors & Collaborators

  • Hospital St. Joseph, Marseille, France

    lead OTHER

Principal Investigators

  • Jean-Baptiste Haumonte · Hopital Saint Joseph Marseille

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2025-09-13
Completion
2025-10-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779735 on ClinicalTrials.gov