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

NCT ID: NCT07077785

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2025-09-15

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.

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.

Conditions

Epidural Anesthesia in Labor and Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Epidural group- group E

Participants in this group will receive epidural analgesia during vaginal delivery

Group Type: EXPERIMENTAL

Epidural Analgesia

Intervention Type: 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.

Control group- group C

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman University Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nezir Yılmaz

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adıyaman University Training and Research Hospital

Adıyaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Nezir Yılmaz

Role: CONTACT

yilmaznezirr@gmail.com

+905068939496

Other Identifiers

ADYU-ANS-NY-011

Identifier Type: -

Identifier Source: org_study_id