Effect of Epidural Analgesia on Labour, Neonatal and Maternal Outcomes. (NCT05579808) | Clinical Trial Compass
CompletedNot Applicable
Effect of Epidural Analgesia on Labour, Neonatal and Maternal Outcomes.
Italy21,808 participantsStarted 2021-06-01
Plain-language summary
Lumbar epidural analgesia is the most used method for reducing labour pain, but its impact on the duration of the second stage of labour and on neonatal and maternal outcomes remains debated. The aim was of the study is to examine whether epidural analgesia affects the course and the outcomes of labour among patients divided according to the Robson-10 group classification system.
Patients of Robson's classes 1, 2a, 3, and 4a were divided into either the epidural analgesia group or the non-epidural analgesia group. A propensity score matching analysis was performed to balance intergroup differences. The primary goal was to analyse the duration of the second stage of labour. The secondary goals were to evaluate neonatal and maternal outcomes.
Who can participate
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:
* pregnant women,
* at term (37-42 weeks),
* admitted to a tertiary university hospital over an 11-year period (October 2008 to October 2019)
Exclusion Criteria:
* multiple pregnancies,
* known major fetal or chromosomal abnormalities,
* pre-labour Caesarean deliveries,
* elective Caesarean deliveries.
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
1
Lenght of 2nd stage
Timeframe: From the time of the first documented full cervical dilatation to delivery