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The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma

NCT07077785 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-22

No results posted yet for this study

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.

Conditions

  • Epidural Anesthesia in Labor and Delivery

Interventions

PROCEDURE

Epidural Analgesia

After informed consent and exclusion of contraindications, an epidural catheter will be placed at the L3-L4 interspace in the sitting position using a Tuohy needle. A test dose of 2 mL lidocaine will be administered to confirm correct catheter placement under continuous monitoring of vital signs. Once cervical dilatation reaches 5 cm, 5 mL of 0.2% bupivacaine combined with 25 mcg fentanyl will be administered via the epidural catheter. Additional boluses will be given as needed based on pain assessment. The catheter will be removed 24 hours postpartum.

Sponsors & Collaborators

  • Adiyaman University Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2025-08-30
Completion
2025-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077785 on ClinicalTrials.gov