Vaginal Misoprostol Before Elective Cesarean Section to Improve Neonatal Respiratory Outcomes . Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- 1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
研究概览
简要总结
Project summary:
Objective: To test the hypothesis that administration of vaginal Misoprostol before elective cesarean section will improve the neonatal respiratory outcomes in late preterm and early term neonates through induction of catecholamine surge.
Design: Randomized controlled clinical trial. Setting: Women health center ,Assiut university hospital. Patients: mothers planned for cesarean section at 34 - 37weeks. Intervention: two hundred and ninety two women will be randomly allocated to receive either 50 micrograms of Misoprostol per vagina within one hour before cesarean section (study group; n= 146) or receive nothing (control group; n = 146) .
Main outcome measure: Apgar score at 1 and 5 minutes.
详细描述
Methodology: After a written informed consent obtained, women who are fitting the inclusion criteria will be randomly allocated using sealed, coded, opaque and sequentially numbered envelopes containing computer generated random numbers into either the study group or the control group. For the study group the enrolled women will receive 50 microgram misoprostol vaginally within 60 minutes before CS. For the control group mothers enrolled will receive nothing.
Observation and data collection: Cardiotocographic monitoring will be undertaken after maternal misoprostol administration to detect any evidence of uterine hyperstimulation and fetal distress.
Ritodrine IV will be used as a tocolytic agent in case of uterine tachysystole. 100 mg of ritodrine will be added to 500 ml of 0.5% dextrose, the solution will be administered as following:
5 drops / minute in the 1st 10 minutes. 10 drops / minute in the next 10 minutes then 15 drops / minute . The clinician should adjust the infusion rate so that the pulse rate doesn't exceed 120b/min and lung bases are free of crepitations.
The surgical and anesthetic teams will be in a state of complete readiness for the ECS from the time of maternal misoprostol administration after enrollment. Details on maternal fluid-electrolyte status during ECS will be recorded as maternal fluid overload is reported to be associated with respiratory distress in the newborn. (SinghiS,Chookang E;1984) blood loss during and 1 hour after the operation will be estimated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women who are planned for elective (planned& pre labor) cesarean section at 34 -37 weeks gestation.
排除标准
- •Pregnancies with known fetal malformation/s or chromosomal aberrations.
- •Presence of absolute contraindication for use of misoprostol.(i.e known hypersensitivity to the drug)
- •Women before 34 and after 37 weeks gestation .
- •Non reassuring cardiotocogram immediately before recruitment.
- •multiple pregnancies.
研究组 & 干预措施
study group
For the study group the enrolled women will receive 50 microgram misoprostol vaginally 60 minutes before CS
干预措施: Misoprostol (Drug)
结局指标
主要结局
1- Rate of Neonatal Intensive Care Unit admission for neonatal respiratory distress.
时间窗: During the first 24 hours of life.
The number of neonates who need Neonatal Intensive Care Unit admission in each study group
次要结局
未报告次要终点
研究者
Ahmed Makhlouf
Professor.Ahmed Mohammed Ahmed Makhlouf
Assiut University