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

Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.

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).

Study Overview

• Status: Recruiting
• Conditions: Prolonged Second Stage of Labor
• Intervention / Treatment: Diagnostic test: Transperineal ultrasound measurements of AOP

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahamia Ahamada; Phone Number: 0033488731071; Email: rahamada@hopital-saint-joseph.fr

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • CHU de Lille - Hôpital Jeanne de Flandre
    • Principal Investigator: Charles GARABEDIAN
  • Marseille, France, 13008
    • Recruiting
    • Hopital Saint Joseph
    • Contact: Rahamia AHAMADA
    • Principal Investigator: Jean-Baptiste Haumonte
  • Marseille, France, 13005
    • Recruiting
    • APHM Hôpital Conception
    • Principal Investigator: Florence BRETELLE
  • Marseille, France, 13015
    • Recruiting
    • APHM Hopital Nord
    • Principal Investigator: Pierre Castel
  • Paris, France, 75012
    • Recruiting
    • Hôpital Armand Trousseau AP-HP
    • Principal Investigator: Anne PINTON
  • Poissy, France, 78300
    • Recruiting
    • CHIC Poissy
    • Principal Investigator: Thibaud QUIBEL
  • Toulon, France, 83000
    • Recruiting
    • CHITS Hôpital Sainte Musse
    • Principal Investigator: Franck MAUVIEL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group 1 : control; The mode of delivery will be determined by clinical examens (digital examination)
Experimental: 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°	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complicated deliveries in each group	A complicated deliveries is defined by the occurrence of at least one of the following events : Failed instrumental extraction; Sequential use of a second instrument,; Difficult instrumental extraction defined as :vacuum detachmentrequires the use of a second instrument,extraction time > 10 minutes,operator's impression of the difficulty of extraction,; Shoulder dystocia by obstetric maneuver	baseline
Severe maternal morbidity, in each group	Severe maternal morbidity is defined by the occurrence of at least one of the following events: postpartum hemorrhage requiring hysterectomy, embolization, conservative surgical treatment or blood transfusion,; third or fourth degree perineal tears; vaginal thrombus,; cervical tear,; surgical wounds; sepsis, amniotic embolism, cardiac complication or renal failure.	1 month
Severe neonatal morbidity, in each group	Severe neonatal morbidity, in each group, defined by the occurrence of at least one event below: severe biological signs; moderate or absent biological signs but associated with perinatal events; seizure; severe neonatal trauma; Fetal death or neonatal death.	1 month
Rate of admission to neonatal intensive care unit, in each group	Number of newborns admitted to intensive care out of the total number of newborns	1 month
Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading	Centralized blind AOP measurement reading	1 month

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Jean-Baptiste Haumonte, Hôpital Saint Joseph Marseille

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): September 13, 2025
• Study Completion (Estimated): October 13, 2025

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cesarean delivery; transperineal ultrasound; angle of progression
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: 2022-A01978-35 DELIVERY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No