Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
研究概览
简要总结
This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.
详细描述
Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18-35 years.
- •Primigravida.
- •The gestational age between 37- 42 weeks.
- •Patient seeking analgesia.
- •Single viable fetus.
- •Vertex presentation.
- •Spontaneous onset of labor.
- •1st stage of labor with cervical dilatation 3-4 cm ( in active phase).
排除标准
- •Extreme of age (below 18-above 35).
- •Multiparity.
- •Multiple gestation.
- •Malpresentation.
- •Major degree of cephalopelvic disproportion.
- •Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
- •Induction of labor.
- •Cervical dilatation exceeds exceeding 4 cm.
- •Use of any other kind of analgesia before recruitment in the study.
- •Scared uterus.
- •Fetal distress.
- •Antepartum hemorrhage.
- •Intrapartum bleeding.
- •Polyhydramnios.
- •Pre-mature rupture of membranes.
- •Intra uterine infections.
- •Hypersensitivity to paracetamol.
研究组 & 干预措施
(1) Active (Paracetamol) arm: n=60
(Paracetamol)
干预措施: (1) Paracetamol injection (Drug)
(2) Placbo (Sterile water) arm: n=60
Sterile water
干预措施: Sterile water (Other)
结局指标
主要结局
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
时间窗: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.
By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
次要结局
- To document safety(Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.)
- To correlate with the duration of labor(Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours.)
研究者
Ahmed Elsayed Hassan Elbohoty
Lecturer in OB GYN
Ain Shams University