Clinical trial NCT05779735: Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate
Official title: Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate : a Randomized Comparative Multicenter Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolonged Second Stage of Labor
Keywords: angle of progression
cesarean delivery
transperineal ultrasound
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: cesarean delivery rate
timeFrame: baseline
Secondary outcomes:
measure: Number of complicated deliveries in each group
timeFrame: baseline
measure: Severe maternal morbidity, in each group
timeFrame: 1 month
measure: Severe neonatal morbidity, in each group
timeFrame: 1 month
measure: Rate of admission to neonatal intensive care unit, in each group
timeFrame: 1 month
measure: Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading
timeFrame: 1 month
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille - Hôpital Jeanne de Flandre
city: Marseille
country: France
facility: APHM Hôpital Conception
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: APHM Hôpital Nord
city: Paris
country: France
facility: Hôpital Armand Trousseau AP-HP
city: Poissy
country: France
facility: CHIC Poissy
city: Toulon
country: France
facility: CHITS Hôpital Sainte Musse
Study officials:
affiliation: Hopital Saint Joseph Marseille
name: Jean-Baptiste Haumonte
role: PRINCIPAL_INVESTIGATOR
References: