TerminatedNot Applicable

A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour

Stopped: the study was stopped due to a change in delivery room practices

France633 participantsStarted 2016-09-21

Plain-language summary

In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia. The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman. Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.

Who can participate

Age range

18 Years

Sex

ALL

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: Age ≥ 18 years * Affiliation to a social security insurance * Written consent given * Singleton pregnancy * Cephalic presentation * ≥37 gestational weeks * Spontaneous onset of labour Exclusion Criteria: * Previous cesarean section * Induction of labour * Intrauterine growth restriction * In utero fetal death * Congenital malformation * Chorioamnionitis * Placenta praevia * Need for an emergency delivery (fetal heart rate abnormalities at admission) * Contra-indication for vaginal delivery * Patient under temporary guardianship, guardianship or judicial protection * Patient included in another study which could interfere with the results of this study

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.

What they're measuring

Cesarean section rate (all causes)

Timeframe: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)

Trial details

NCT IDNCT02741141

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-07

View on ClinicalTrials.gov More Dystocia trials