Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 848
- 试验地点
- 1
- 主要终点
- Incidence of respiratory morbidity
研究概览
简要总结
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
详细描述
Antenatal corticosteroid (ACS) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. Recently, it has been suggested that ACS may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. On the contrary, there is a paucity of information regarding the effectiveness of ACS in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of ACS in twin pregnancies based on the evidences in singleton pregnancies. However, the effect of ACS in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. This study aims to determine the effectiveness of ACS in late preterm twin neonates.
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
- Double (Participant, Care Provider)
盲法说明
Enrolled women will be randomly assigned in a 1:1 ratio to ACS (Group 1) or placebo (Group 2). The randomization will be done by web-based randomization system which is operated by medical research collaborating center of Seoul National University Hospital. The ACS or placebo will be prepared by unblended researchers [clinical trial pharmacy]. Unblinded researchers will be designated at the beginning of this trial, and they will not participate in the subsequent process of data management and data analysis. Neither the enrolled pregnant women nor the other investigators (except predeterminate unblinded researchers) will be aware of the result of random assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(1) Age over 18 years
- •(2) Twin pregnant women at 34weeks 0days to 36weeks 5days of gestation
- •(3) At risk for preterm birth such as preterm labor, preterm prematrue rupture of membrane or maternal-fetal indications that need preterm delivery. Preterm labor is defined as regular uterine contractions with or without the following symptoms; pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical changes
- •(4) Availability of written informed consent.
排除标准
- •(1) Gestational age before 34weeks 0days or after 36weeks 6days
- •(2) Lethal major fetal anomaly, fetal distress or fetal death in utero
- •(3) Expected to deliver within 12 hours; for example, advanced cervical dilatation (>8cm) in preterm labor or active phase labor (cervical dilatation>4cm) in preterm premature rupture of membranes
- •(4) History of a previous administration of ACS before 34weeks of gestation for fetal lung maturation
- •(5) Administration of systemic steroid for medical indications
- •(6)Diagnosis of clinical chorioamnionitis Fever >37.8 and the presence of two more following conditions: uterine tenderness, foul-odored vaginal discharge, maternal leukocytosis(>1500), maternal tachycardia(>100) or fetal tachycardia(>160)
研究组 & 干预措施
ACS (Group 1)
Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
干预措施: Betamethason Sodium Phosphate (Drug)
Placebo (Group 2)
Intramuscular injection of normal saline 3ml twice 24hours apart
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of respiratory morbidity
时间窗: 72 hours after birth
NICU admission, Continuous positive airway pressure, High flow nasal cannula for ≥12 continuous hours, Fraction of inspired oxygen of ≥ 0.3, Mechanical ventilation use, ECMO use and Stillbirth or neonatal death within 72hours after death
次要结局
- Surfactant use(28 days after birth)
- Transient tachypnea of the newborn, apnea(72 hours after birth)
- Bronchopulmonary dysplasia;BPD(28 days after birth)
- Respiratory distress syndrome(72 hours after birth)
- Maternal complication(72 hours after birth)
- Need for resuscitation at birth(at birth)