Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate (NCT05779735) | Clinical Trial Compass
UnknownNot Applicable
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate
France182 participantsStarted 2023-09-13
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.