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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2025-10-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Prolonged Second Stage of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1 : control

The mode of delivery will be determined by clinical examens (digital examination)

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 : Transperineal ultrasound measurements of AOP

The mode of delivery will be determined by clinical examens (digital examination) and ultrasound measurement of the AOP :

* vaginal delivery is encouraged if AOP measurement is \>120°
* cesarean delivery is encouraged if AOP measurement is \<= 120°

Group Type EXPERIMENTAL

Transperineal ultrasound measurements of AOP

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound
* uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours),

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No