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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 ass

Первичные конечные точки

• Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress [Срок оценки: 1 month postpartum]

Вторичные конечные точки (1)

• Pain Intensity During Labor Assessed by Visual Analog Scale (VAS) [Срок оценки: From labor onset until discharge (approximately 0 to 48 hours postpartum)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Turkey (Türkiye) · 1 центр

• Adıyaman University Training and Research Hospital — Adıyaman

Идентификаторы

NCT: NCT07077785 · ADYU-ANS-NY-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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