Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,510
- 试验地点
- 19
- 主要终点
- Respiratory morbidity
研究概览
简要总结
This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
详细描述
Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this the participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for / high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).
- •Criteria for determination of late preterm delivery risk:
- •Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
- •Spontaneous rupture of the membranes
- •Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider.
排除标准
- •They had already received a full course of betamethasone.
- •Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.
- •Prior ACS treatment
- •Current known or suspected infection ( viral, bacterial or other)
- •Pre-gestational diabetes mellitus.
- •Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language
结局指标
主要结局
Respiratory morbidity
时间窗: first 72 hours after birth
1. Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours 2. Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours 3. Mechanical ventilation in the firdt 72 hours yes/no 4. extracorporeal membrane oxygenation (ECMO) yes/no 5. TTN: transient tachypnea of newborn yes/no
次要结局
- other neonatal morbidities other neonatal morbidities(first 30 days after birth)
研究者
Ron Beloosesky MD
Head of ultrasound in obstetrics and gynecology
Rambam Health Care Campus