Effect of combined spinal-epidural analgesia during labour on post partum depression: a controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Prevalence(frequency in percentage) of post partum depression using EPDS questionnaire
研究概览
简要总结
This study is a randomised, prospective,open labled trial to evaluate the effect of combined spinal epidural analgesia during labour on post partum depression.The index group receiving the neuraxial block would be compared with the control normal vaginal delivery group for post partum depression, using the Edinburgh postnatal depression scale(EPDS) at 3 days and 6 weeks. The primary outcome measure would be prevalence(frequency in percentage) of post partum depression using EPDS questionnaire. The secondary outcome and observational measures would include Maternal satisfaction( based on score of Visual Analog scale), Pain score(VAS Score), Sensory and motor block characteristics, Haemodynamic parameters of mother, Foetal heart rate, Duration of second stage of labour, Mode of delivery, Apgar scores and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA Grade 1 and 2 Age more than 18 years Primigravida Single gestation Cephalic presentation at 37 completed weeks of gestation In early spontaneous labour(cervical dilation < 5cm) Baseline pain score>30(on a VAS of 0-100) Able to use PCEA pump Parturients consenting to participate in the study.
排除标准
- •Refusal by parturient Patient failing to understand the functioning of PCEA pump and VAS scoring History of psychiatric disorder(GHQ12>2) Obesity(Wt>100kg) Parturients who have received oral or parenteral analgesics in the last 4 hours Systemic and local sepsis Deranged coagulation profile Preterm labour(<37 commpleted weeks) Obstetric complications(eg., PROM) Foetus with a non re-assuring NST Foetus with known or suspected congenital anomalies Allergy to study drugs i.e., levobupivacaine, fentanyl Patient with Diabetes(pre-existing or gestational) or history of immunosuppression.
- •Patients with hypertension on methyldopa.
结局指标
主要结局
Prevalence(frequency in percentage) of post partum depression using EPDS questionnaire
时间窗: Day 3 and 6 weeks
次要结局
- Maternal satisfaction(VAS score)(Pain score(VAS score))