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

NCT07077785 | Not Yet Recruiting

• 1 other identifier: ADYU-ANS-NY-011
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

epidural analgesia; maternal-infant bonding; Psychological Birth Trauma

Outcome Measures

Primary Outcomes (1)

• Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress

  Assessment of maternal-infant bonding quality using the Maternal Attachment Inventory (MAI) and evaluation of birth-related psychological stress using a validated childbirth trauma scale. Outcomes will be measured via structured questionnaires administered at 1 month postpartum to evaluate the psychological impact of epidural analgesia during vaginal delivery.

  1 month postpartum

Secondary Outcomes (1)

• Pain Intensity During Labor Assessed by Visual Analog Scale (VAS)

  From labor onset until discharge (approximately 0 to 48 hours postpartum)

Other Outcomes (1)

• Maternal Satisfaction with the Birth Experience

  Within 48 hours postpartum (prior to discharge)

Study Arms (2)

Epidural group- group E

EXPERIMENTAL

Participants in this group will receive epidural analgesia during vaginal delivery

Procedure: Epidural Analgesia

Control group- group C

NO INTERVENTION

Participants in this group will undergo vaginal delivery without receiving any form of neuraxial analgesia.

Interventions

Epidural Analgesia PROCEDURE

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.

Epidural group- group E

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female participants who are pregnant and undergoing vaginal delivery will be eligible for inclusion in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman University Training and Research Hospital

Adıyaman, 02200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Nezir Yılmaz

CONTACT

+905068939496; yilmaznezirr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation. Although study participants and clinical staff involved in labor management are aware of the intervention status, the researchers who administered epidural analgesia will not participate in data collection or outcome evaluation. Therefore, the evaluation of questionnaire responses and study outcomes will be conducted independently, without knowledge of the participants' group assignment, ensuring assessor-level blinding.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This is a prospective, randomized, single-center, parallel-group clinical study designed to evaluate the psychological impact of epidural analgesia on childbirth-related outcomes. The study will compare two groups of women undergoing vaginal delivery: those receiving epidural analgesia and those not receiving it. Outcomes such as perceived pain (VAS), maternal satisfaction, psychological stress related to childbirth, and early maternal-infant bonding will be assessed through validated scales administered during hospitalization and at 1-month postpartum.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: July 25, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 15, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

TU (1)