A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 437
- 试验地点
- 21
- 主要终点
- Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
研究概览
简要总结
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.
详细描述
This is a randomized double-blinded placebo-controlled trial. The objective of this study is to evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in patients delivering prior to 34 weeks' gestation in a randomized prospective fashion.
Preterm delivery occurs in approximately 10% of all deliveries in the United States. Preterm birth is the cause of 75% of neonatal mortality not mentioning the significantly increased morbidity from respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and sepsis. Numerous studies have evaluated the safety and efficacy of antenatal corticosteroid (ACS) administration in threatened preterm labor.
National Institutes of Health (NIH) first consensus conference in 1994 evaluated the research in this field. Conclusions included the clear evidence that antenatal corticosteroids decrease the incidence of RDS in infants born at 29-34 weeks gestation, with a decrease in RDS severity for infants born at 24-28 weeks gestation and a decrease in the incidence of intraventricular hemorrhage in infants born at 24-28 weeks gestation without harm to mother or fetus. Their recommendation was to give a single course of corticosteroids to all pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days.
Since the studies on the duration of the effects of antenatal corticosteroids in the fetus are not conclusive, many obstetricians repeat corticosteroids weekly or bi-weekly to patients continuing to be at risk for preterm delivery. Lacking scientific evidence, many investigators have performed retrospective analyses regarding the effects of single-course versus multiple-course antenatal corticosteroids.
The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated courses of corticosteroids are suggestive of possible benefits, especially in reduction of RDS, however, design flaws limit their validity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •25 to 32 6/7 weeks gestation
- •Singleton or twin gestation
- •Received 1st course of betamethasone prior to 30 weeks' gestation
- •Began 1st course of betamethasone at least 14 days prior to randomization
- •Risk of delivery in next 7 days due to either maternal or fetal complication (e.g. preterm labor, severe preeclampsia, IUGR, etc.)
- •Intact membranes
排除标准
- •Known major fetal anomalies (eg: anencephaly, renal agenesis etc...)
- •High order multiple gestation (triplets or higher)
- •Cervical dilation > 5 cm
- •Clinical chorioamnionitis prior to initiation of second course (two or more of the following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal tachycardia (>160 beats/min), or white blood cell count >20x109/L.define)
- •Ruptured membranes prior to initiation of second course of betamethasone
- •Already receiving corticosteroids for other conditions (e.g. Lupus, asthma)
- •Maternal condition contraindicating the use of steroids (e.g. HIV, active Tuberculosis)
- •Participation in conflicting study
研究组 & 干预措施
1 Test group
Receive 2nd Course = Study drug (betamethasone or dexamethasone)
干预措施: Betamethasone or Dexamethasone (2nd course of ACS) (Drug)
2 - Control
Placebo group = received placebo course
干预措施: Placebo (Drug)
结局指标
主要结局
Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.
时间窗: From birth to 28 days of life
This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death
次要结局
- Number of Neonates Who Required Surfactant Therapy After Birth.(Birth to 28 days of life)
- Number of Neonates With Pneumothorax(birth to 28 days of life)
- Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.(Measured at birth.)
- Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.(birth to 28 days of life)
- Maternal Infectious Morbidity.(Up to 28 days after giving birth)
- Neonatal Birth Weight Reported in Grams(At time of Birth)
- Neonatal Head Circumference Taken at Time of Birth.(Birth)
- Gestational Age at (@) Delivery(gestational age at delivery in weeks of gestation)