Impact of Low-Dose Epidural Analgesia on Labour Progression in Low-Risk Women (NCT06987591) | Clinical Trial Compass
CompletedNot Applicable
Impact of Low-Dose Epidural Analgesia on Labour Progression in Low-Risk Women
Italy5,995 participantsStarted 2023-10-01
Plain-language summary
Aim of the study was to analyse data on cervical dilation and fetal descent patterns in low-risk women, who did or did not receive intermittent low-dose epidural analgesia (EA), and who had either a vaginal or a caesarean delivery.
Therefore, we conducted a retrospective analysis, retrieving data from October 1st 2008 to October 31st 2018. We selected 6030 women categorized as Robson Group 1, divided into four groups according to the mode of delivery (vaginal or caesarean) and the presence of EA:
* Vaginal delivery with EA (VD-e)
* Vaginal delivery without EA (VD-n)
* Caesarean delivery with EA (CD-e)
* Caesarean delivery without EA (CD-n)
Who can participate
Age range
18 Years – 40 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:
* Robson class 1 (nulliparous, single, cephalic full-term pregnancy with spontaneous labour)
* maternal age between 18 and 40 years
* neonatal weight between 2500 and 4000 grams
* cervical dilation \<7 cm at admission in the delivery suite
Exclusion Criteria:
* minimal duration of labour \< 3 hours (from admission to the delivery suite to delivery)
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
Cervical dilation curve
Timeframe: First stage of labour (from admission to the delivery suite to full cervical dilation)
2
Fetal head descent curve
Timeframe: From admission to the delivery room up to the time of delivery (either via vaginal route or caesarean section)