A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 194
- 试验地点
- 9
- 主要终点
- Composite Neonatal Morbidity
研究概览
简要总结
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
详细描述
This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants age 18 years or older
- •24w0d to 32w6d weeks gestation
- •Singleton pregnancy
- •Received first course of ACS at or prior to 31w6d gestation
- •Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
- •Expectant management planned
- •Premature Ruptured membranes (PROM) before onset of labor
排除标准
- •Known major fetal anomalies
- •Multiple gestation
- •Not a candidate for expectant management
- •Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
- •Already receiving corticosteroids for another condition
- •Any contraindications to the maternal use of corticosteroids
研究组 & 干预措施
Betamethasone - ACTIVE
Booster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses]
干预措施: Betamethasone - ACTIVE (Drug)
normal saline - PLACEBO
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
干预措施: Normal Saline - PLACEBO (Other)
结局指标
主要结局
Composite Neonatal Morbidity
时间窗: from birth through the first 28 days of life
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
次要结局
- Gestational age of baby(measured within the first 24 hours following birth.)
- Baby's birth weight(measured within the first 24 hours following birth)
- Intrauterine growth restriction (IUGR)(anytime during the pregnancy prior to birth (~ 9 months of pregnancy))
- Baby's Head Circumference(measured within the first 24 hours following birth)
- Newborn Mechanical Ventilatory days(measured from birth to 28 days following birth)
- Newborn Oxygen support days(measured from birth to 28 days following birth)
- Newborn Surfactant therapy(measured within the first 24 hours following birth)
- time from first dose of study drug to birth(measured in days/hours from the time of administration of first study drug until birth.)
- Newborn Hospital Days(measured within the first 24 hours following birth)
- Pneumothorax(measured within the first 24 hours following birth)
- Maternal Infectious Morbidity(measured within the first 24 hours following birth)