The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma (NCT07077785) | Clinical Trial Compass
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The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma
Turkey (Türkiye)80 participantsStarted 2025-07-25
Plain-language summary
This prospective, single-center study aims to evaluate the effects of epidural analgesia on maternal-infant bonding and perceived birth-related trauma in women undergoing vaginal delivery. Participants will be divided into two groups: those who receive epidural analgesia and those who deliver without it. Standardized questionnaires will be used to assess pain perception, maternal satisfaction, and the quality of early bonding between mother and infant. The study is designed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with approval from the local ethics committee.
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:
Female participants aged between 18 and 40 years
ASA physical status classification I or II
Pregnant women undergoing spontaneous vaginal delivery at the study hospital
Willingness to provide informed consent and participate in study procedures
Exclusion Criteria:
Age below 18
ASA physical status classification III or IV
Morbid obesity (BMI ≥ 40 kg/m²)
Indication for cesarean section
History of local anesthetic toxicity or allergy
Contraindications to epidural analgesia (e.g., coagulopathy, infection at insertion site)
Any significant maternal or fetal complication that contraindicates study participation
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
Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress