Timing of Elective Caesarean Section and Neonatal Morbidity - a Randomised Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,273
- 试验地点
- 14
- 主要终点
- Neonatal Admission After Elective Caesarean Section
研究概览
简要总结
The caesarean section rate is rising globally. About 10% of the newborns are submitted to a neonatal department after planned caesarean section, primarily with respiratory disorders. More children are submitted if caesarean is performed earlier in pregnancy.
Study hypothesis: More newborns are admitted after planned caesarean at 38 weeks and 3 days of gestation than after 39 weeks and 3 days of gestation.
Aim of study: To compare elective caesarean section performed at 38 weeks and 3 days of gestation with 39 weeks and 3 days of gestation. According to this timing to determine the proportion of newborns admitted within 48 hours after birth.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective caesarean section
- •Gestational age determined at 12 weeks ultrasound scan
- •Singleton pregnancy
排除标准
- •< 18 years of age (at time of randomization)
- •In need of an interpreter to communicate in danish
- •Diabetes, both gestational and before pregnancy
- •A mother with an estimated high risk of caesarean section before 39+5 weeks
结局指标
主要结局
Neonatal Admission After Elective Caesarean Section
时间窗: 48 hours
次要结局
- Maternal Satisfaction With Timing of Elective Caesarean Section(2 months)
- Post Partum Depression(2 months)
- Neonatal Diagnoses(30 days)
- Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics(30 days)
- Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.(30 days)
- Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission(30 days)
- Pediatric Admission and Morbidity(From birth until 2 years of age)
研究者
Julie Glavind
MD, PhD
Aarhus University Hospital