Effect of Antenatal Corticosteroids on Neonatal Morbidity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Neonatal Respiratory distress syndrome
研究概览
简要总结
It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.
详细描述
The study will be a double blind randomised controlled trial. There will be two study groups and one control group.
The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.
The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.
The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
- •Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.
排除标准
- •Evidence of Chrioamnionitis.
- •Evidence of foetal distress.
- •History of use of antenatal corticosteroids in index pregnancy.
- •Women who do not give consent.
研究组 & 干预措施
Dexamethasone sodium phosphate injection
Intervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China)
干预措施: Dexamethasone Sodium Phosphate Injection (Drug)
Betamethasone sodium phosphate injection
Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0)
干预措施: Betamethasone Sodium Phosphate Injection (Medication) (Drug)
Water for injection
Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart.
干预措施: Water for injection (Drug)
结局指标
主要结局
Neonatal Respiratory distress syndrome
时间窗: Within the first 72 hours of life
Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.
次要结局
- Transient tachypnoea of the newborn:(Within the first 72 hours after delivery/birth)
- Admission into neonatal intensive care unit.(Within the first 72 hours after delivery/birth)
- 2. Admission into neonatal intensive care unit. Apnoea.(Within the first 72 hours after delivery/birth)
研究者
Anisah Yahya
Lecturer I/Fellow
Ahmadu Bello University Teaching Hospital