Effect of Single Dose Antenatal Betamethasone on the Incidence of Neonatal Respiratory Morbidity After Elective Cesarean Section at Term: A Prospective Double Blinded Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percentage of patients with respiratory morbidity
研究概览
简要总结
Patients undergoing elective C-section will be randomized into two groups. The first group will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The second group will receive placebo.
详细描述
This is a prospective double blinded randomized clinical trial. Patients will be randomized into two groups. Group A will receive one dose of Betamethasone at least 24 hours before scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be studied in order to assess the effect of Betamethasone on respiratory morbidity of the newborn infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 17 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with singleton or multiple gestation,
- •between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)
排除标准
- •any medical problem that could affect fetal well-being;
- •evidence of intrauterine infection,
- •oligohydramnios,
- •fetal congenital malformations,
- •preeclampsia,
- •maternal hypertension,
- •severe fetal rhesus sensitization,
- •antepartum hemorrhage,
- •Intrauterine growth restriction
- •preterm rupture of membranes
- •preterm delivery
- •previously received antenatal steroids less than one month ago
- •those who decline to participate in the study.
结局指标
主要结局
Percentage of patients with respiratory morbidity
时间窗: at birth
Neonatal respiratory morbidity will be assessed through oxygen saturation, Apgar score and Silverman score
次要结局
- Admission to Neonatal Intensive Care Unit (NICU)(up to 2 weeks)
研究者
Manal Hubeish
Principal Investigator
Makassed General Hospital