Effects of Antenatal Corticosteroids in Patients With Early (22 - 23w6d) Threatened Preterm Birth
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pediatrix
- 主要终点
- Composite Neonatal Morbidity
研究概览
简要总结
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.
详细描述
The purpose of this study to evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 0/7 and 23 6/7 weeks at the time of admission. If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration, the patient is eligible to be randomized. Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age: those at 22 0/7 to 22 6/7 weeks and those at 23 0/7 weeks to 23 6/7 weeks. Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below:
- 2 doses of Betamethasone, 12 mg intramuscularly (IM), 24 hours apart, or if as in some hospitals occasionally occurs and betamethasone is unavailable -
- 4 doses of Dexamethasone IM 6 mg, 12 hours apart.
Remainder of care will be at the discretion of the clinician.
Randomized 22 0/7 - 22 6/7:
For patients randomized between 22 0/7 and 22 6/7 weeks and who are undelivered > 24 0/7 weeks, the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age at time of study entry
- •Gestational age between 22 0/7 to 23 6/7 weeks, inclusive at time of randomization regardless of whether the provider and patient decide to consider the fetus viable and provide obstetric interventions and cesarean section if needed.
- •Singleton pregnancy
- •Threatening to deliver by the best estimate of the clinician within the ensuing week
- •Thought by the clinician to be able to delay delivery at least 3 hours from the time of randomization.
- •Desired Pregnancy
- •All clinical complications related to or leading to delivery except those listed as exclusion criteria are eligible. All of the following clinical complications are eligible including but not limited to:
- •premature labor,
- •incompetent cervix with or without prolapsing membranes,
- •Preterm Premature Rupture of the membranes (PPROM),
- •chorioamnionitis,
- •all hypertensive disorders of pregnancy,
- •vaginal bleeding due to placenta previa, abruption or unknown etiology,
- •being delivered for medical complication of pregnancy, and others.
排除标准
- •Maternal history of insulin dependent diabetes
- •Known congenital fetal anomaly
- •Known Hydrops fetalis with this current pregnancy
- •Severe intrauterine growth restriction < 10% percentile
- •Patient receiving corticosteroids for other maternal indications other than for fetal lung maturity
- •Patient with h/o HIV or active Tuberculosis.
- •Any other known contraindication to corticosteroids
研究组 & 干预措施
Betamethasone
Betamethasone: 12 mg given intramuscularly (IM), 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable - • 4 doses of Dexamethasone IM 6 mg, 12 hours apart
干预措施: Betamethasone (Drug)
Normal Saline
Quantity Sufficient (QS) of Normal Saline (NS) given intramuscularly (IM), 24 hours apart or if hospital is using Dexamethasone in place of Betamethasone then administer NS x 4 doses 12 hours apart
干预措施: Placebo (Genetic)
结局指标
主要结局
Composite Neonatal Morbidity
时间窗: First 30 days after birth
Defined as one or more of the following: fetal death, neonatal death within 30 days of delivery, respiratory distress syndrome (oxygen requirement, clinical diagnosis and consistent chest x-ray), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia, blood culture proven sepsis, necrotizing enterocolitis (NEC).
次要结局
- Need for Newborn Surfactant Therapy(First 30 days after birth)
- Preterm Birth prior to 34weeks gestational age.(From entry into the study until 34 weeks gestational age.)
- Respiratory Distress Syndrome (RDS)(First 30 days after birth)
- Birth Weight(Measured at time of birth)
- Newborn Head Circumference measurement(Measured at time of birth)