EPidural's Impact on Contractions and Fetal REsponse (NCT06860854) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EPidural's Impact on Contractions and Fetal REsponse
Poland200 participantsStarted 2025-03-17
Plain-language summary
This prospective observational study aims to assess the impact of epidural analgesia (ELA) on uterine contractility, cardiotocography (CTG) patterns, and maternal-fetal hemodynamics in term pregnancies. The study will recruit 200 laboring patient receiving ELA and evaluate changes in uterine contractions, Doppler blood flow parameters, and fetal heart rate tracings before and after ELA administration. Secondary analyses will compare outcomes between primiparous and multiparous women, as well as between uncomplicated and complicated pregnancies. Pain relief effectiveness will be correlated with observed changes. This study will provide a comprehensive understanding of ELA's effects on labor progression and fetal well-being, addressing gaps in existing research.
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:
* ≥ 18 years old
* singleton pregnancy
* signed informed consent form
* patients in labor
* cervical dilation ≥ 3cm,
* patient requesting and eligible for epidural analgesia
* normal CTG trace for at least 30 minutes before epidural analgesia
Exclusion Criteria:
* \< than 18 years old
* preterm delivery
* labor induced or stimulated by oxytocin
* multiple pregnancy
* fetal malformations
* \< than 3cm cervical dilation
* lack of CTG trace for at least 30 minutes before epidural analgesia
* patient not requesting or not eligible for epidural analgesia
* informed consent form not signed
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
Changes in uterine contractility
Timeframe: From enrollment to 120 minutes after the administration of epidural analgesia
2
Changes in maternal and fetal doppler velocities
Timeframe: From enrollment to 24 hours after labor
3
Changes in cardiotocography (CTG) patterns
Timeframe: From enrollment up to 120 minutes after the administration of epidural
Trial details
NCT IDNCT06860854
SponsorCentral Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland