NCT05779735

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Hospital St. Joseph, Marseille, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prolonged Second Stage of Labor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-13
• Primary completion: 2025-09-13
• Completion: 2025-10-13
• First posted: 2023-03-22
• Last updated: 2024-02-15

Locations

7 sites across 1 country: France