Neonatal Metabolic Effect Of Epidural Labor Analgesia With or without Music Therapy: A prospective, Randomised, comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Neonatal metabolic parameters (cord blood glucose, lactate, pH, base deficit), APGAR score at 1 & 5 minutes, and NICU admission.
研究概览
简要总结
This prospective randomized comparative study will be conducted in the Department of Anesthesiology in collaboration with Obstetrics and Gynecology at King George’s Medical University, Lucknow, over 18 months. Ninety primiparous women with singleton pregnancies in active labor will be randomized (computer-generated sequence, allocation concealed by SNOSE) into two groups: Group A receiving epidural analgesia alone (ropivacaine 0.1% + fentanyl 2 µg/ml) and Group B receiving epidural analgesia with adjunct music therapy (instrumental piano, 60–80 bpm, 50–60 dB). The primary outcome will be neonatal metabolic parameters (cord blood glucose, lactate, pH, base deficit), APGAR scores at 1 and 5 minutes, and NICU admission. Secondary outcomes include maternal satisfaction and any maternal or neonatal adverse events. The target sample size is 90 (45 per group). This open-label trial is categorized as Phase N/A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •pregnant women above 18 years of age with singleton pregnancy, ASA physical status I and II, and cervical dilation greater than three centimeters.
- •Written informed consent was obtained from all participants.
排除标准
- •women with a history of previous caesarean section, those with complicated obstetric conditions such as twin pregnancy, antepartum hemorrhage, placenta previa, gestational diabetes, or moderate to severe preeclampsia, and women with pre-existing medical conditions likely to affect labour or neonatal outcomes.
- •Participants with contraindications to epidural analgesia, hearing impairment, or refusal to listen to music were also excluded.
结局指标
主要结局
Neonatal metabolic parameters (cord blood glucose, lactate, pH, base deficit), APGAR score at 1 & 5 minutes, and NICU admission.
时间窗: at birth
次要结局
- Maternal and neonatal adverse events, if any, during labor and delivery.(whole intrapartum period)
研究者
Dr M KRoja
King Georges Medical University
