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

Prolonged Second Stage of Labor Clinical Trial

— DELIVERY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779735
• Other study ID #: 2022-A01978-35 DELIVERY
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: October 13, 2025

Study information

• Verified date: February 2024
• Source: Hospital St. Joseph, Marseille, France
• Contact: Rahamia Ahamada
• Phone: 0033488731071
• Email: rahamada[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: October 13, 2025
• Est. primary completion date: September 13, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Prolonged Second Stage of Labor

Intervention

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

Locations

Country	Name	City	State
France	CHU de Lille - Hôpital Jeanne de Flandre	Lille
France	APHM Hôpital Conception	Marseille
France	APHM Hôpital Nord	Marseille
France	Hopital Saint Joseph	Marseille
France	Hôpital Armand Trousseau AP-HP	Paris
France	CHIC Poissy	Poissy
France	CHITS Hôpital Sainte Musse	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 detachment; requires the use of a second instrument,; extraction time > 10 minutes,; operator's impression of the difficulty of extraction,; Shoulder dystocia by obstetric maneuver	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Concordance rate between the routinely AOP measurement and the centralized AOP measurement reading	Centralized blind AOP measurement reading	1 month