NCT07077785

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Adiyaman University Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-25
• Primary completion: 2025-08-30
• Completion: 2025-09-15
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: Turkey (Türkiye)