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

Hospital Saint Joseph

Status: Enrolling

Conditions: Prolonged Second Stage of Labor

Treatments: Diagnostic Test: Transperineal ultrasound measurements of AOP

Study type: Interventional

Funder types: Other

Identifiers

NCT05779735

2022-A01978-35 DELIVERY

Details and patient eligibility

About

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).

Enrollment: 182 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Group 1 : control

No Intervention group

Description:

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

Group 2 : Transperineal ultrasound measurements of AOP

Experimental group

Description:

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°

Treatment:

Diagnostic Test: Transperineal ultrasound measurements of AOP