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NCT Number: NCT07077785

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

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 randomly allocated to receive either labor epidural analgesia or standard non-neuraxial analgesic care. 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Adıyaman University Training and Research Hospital

Adıyaman, 02200, Turkey (Türkiye)

About this study

This prospective, randomized, controlled, 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(City Birth 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 month postpartum

    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. Score range: 26-104; higher scores indicate stronger maternal-infant attachment.

Secondary outcomes

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

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

    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. Minimum score: 0; maximum score: 10. Higher scores indicate greater pain intensity, while lower scores indicate less pain.

Other outcomes

  1. Maternal Satisfaction with the Birth Experience

    Time frame: Within 48 hours postpartum (prior to discharge)

    Assessment of maternal satisfaction with the childbirth experience using a verbal four-point rating scale administered prior to hospital discharge. Score range: 1-4 (1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent) Higher scores indicate greater maternal satisfaction.

Sponsors and collaborators

Lead sponsor

Adiyaman University Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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