CompletedNot Applicable

PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous

France304 participantsStarted 2013-06

Plain-language summary

Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates. To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.

Who can participate

Age range

18 Years – 44 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 patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension \<4cm and eligible for an epidural analgesia * Patient has signed informed consent * Patient affiliated or beneficiary of a social medical insurance * Patient aged between 18 and 44 years old Exclusion Criteria: * Morphinic administration before the care * Anomaly of fetal cardiac rate * Fetal or maternal anomalies wich don't allow to evaluate motor block * Known uterine malformation * Contraindications for thrusts for pregnancy * Patient protected by law * Patient under guardianship

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

Occurence of a specific clinical criteria which can lead to a complication of the delivery

Timeframe: Up to 10 hours

Trial details

NCT IDNCT01856166

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

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