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

The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma in Women Undergoing Vaginal Delivery With Epidural Analgesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epidural Anesthesia in Labor and Delivery
• Intervention / Treatment: Procedure: Epidural Analgesia

Detailed Description

This study is a prospective, non-interventional, single-center clinical trial that will be conducted at Adıyaman University Training and Research Hospital, Department of Obstetrics and Gynecology. The aim is to investigate the impact of epidural analgesia on maternal-infant bonding and birth-related psychological trauma among women undergoing spontaneous vaginal delivery.

Eligible participants will include pregnant women aged between 18 and 40 years with ASA physical status I or II, who are planning vaginal delivery. Women with contraindications to epidural analgesia, morbid obesity, previous local anesthetic toxicity, or indications for cesarean section will be excluded.

Based on a priori power analysis, 40 participants will be recruited into each group to account for potential dropout, totaling 80 participants. Group E will consist of women who receive epidural analgesia during labor, while Group C will include those who undergo vaginal delivery without any epidural intervention.

Epidural analgesia will be administered via catheter placement at the L3-L4 vertebral level. Following a test dose with lidocaine, patients will receive a combination of 0.2% bupivacaine and 25 mcg fentanyl once cervical dilatation reaches 5 cm. Additional boluses may be administered as required based on pain levels.

Participants will be assessed for pain intensity using the Visual Analog Scale (VAS) during and after delivery. Postpartum satisfaction and early breastfeeding status will be recorded prior to discharge. At one month postpartum, all participants will complete validated questionnaires, including a birth-related trauma scale and the Maternal Attachment Inventory, to assess psychological outcomes and maternal-infant bonding.

The results of this study are expected to contribute to a better understanding of the psychological and emotional consequences of epidural analgesia in vaginal deliveries and help optimize maternal care practices.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nezir Yılmaz; Phone Number: +905068939496; Email: yilmaznezirr@gmail.com

Study Locations

• Turkey
  • Adıyaman, Turkey, 02200
    • Adıyaman University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural group- group E; Participants in this group will receive epidural analgesia during vaginal delivery	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.
No Intervention: Control group- group C; Participants in this group will undergo vaginal delivery without receiving any form of neuraxial analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity During Labor Assessed by Visual Analog Scale (VAS)	Evaluation of maternal pain intensity during labor using the Visual Analog Scale (VAS). Pain scores will be recorded at predefined intervals, including active labor and immediately postpartum.	From labor onset until discharge (approximately 0 to 48 hours postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Satisfaction with the Birth Experience	Assessment of maternal satisfaction regarding the childbirth process using a validated satisfaction questionnaire administered prior to hospital discharge.	Within 48 hours postpartum (prior to discharge)

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: July 12, 2025
• First Submitted That Met QC Criteria: July 12, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: epidural analgesia; maternal-infant bonding; Psychological Birth Trauma
• Other Study ID Numbers: ADYU-ANS-NY-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No