NCT05779735

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

March 9, 2023

Last Update Submit

February 14, 2024

Conditions

Prolonged Second Stage of Labor

Keywords

angle of progressioncesarean deliverytransperineal ultrasound

Outcome Measures

Primary Outcomes (1)

  • cesarean delivery rate

    Demonstrate that the angle of progression measurement would change by 20% the cesarean rate after a prolonged second stage of labor (2 hours).

    baseline

Secondary Outcomes (5)

  • Number of complicated deliveries in each group

    baseline

  • Severe maternal morbidity, in each group

    1 month

  • Severe neonatal morbidity, in each group

    1 month

  • Rate of admission to neonatal intensive care unit, in each group

    1 month

  • Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading

    1 month

Study Arms (2)

Group 1 : control

NO INTERVENTION

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

Group 2 : Transperineal ultrasound measurements of AOP

EXPERIMENTAL

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°

Diagnostic Test: Transperineal ultrasound measurements of AOP

Interventions

Transperineal ultrasound measurements of AOPDIAGNOSTIC_TEST

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

Group 2 : Transperineal ultrasound measurements of AOP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de Lille - Hôpital Jeanne de Flandre

Lille, 59000, France

RECRUITING

APHM Hôpital Conception

Marseille, 13005, France

RECRUITING

Hopital Saint Joseph

Marseille, 13008, France

RECRUITING

APHM Hôpital Nord

Marseille, 13015, France

RECRUITING

Hôpital Armand Trousseau AP-HP

Paris, 75012, France

RECRUITING

CHIC Poissy

Poissy, 78300, France

RECRUITING

CHITS Hôpital Sainte Musse

Toulon, 83000, France

RECRUITING

Study Officials

  • Jean-Baptiste Haumonte

    Hopital Saint Joseph Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahamia Ahamada

CONTACT

0033488731071rahamada@hopital-saint-joseph.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

September 13, 2023

Primary Completion

September 13, 2025

Study Completion

October 13, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

FR(7)