Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Gestational age at delivery
研究概览
简要总结
To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation
详细描述
Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with preterm labor admitted to hospital and treated with tocolysis
- •pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length < 15 mm
- •single pregnancy
- •normal amniotic fluid
- •normal arterial ductus
排除标准
- •Age below 18 years
- •previous use of indomethacin in the index pregnancy
- •chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery.
- •oligohydramnios
- •allergy to NSAID
- •previous history of gastrointestinal bleeding
- •use of NSAID contraindicated
- •not adherence to the study
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
indomethacin
50 mg/ 6 hours of indomethacin oral use
干预措施: indomethacin (Drug)
结局指标
主要结局
Gestational age at delivery
时间窗: before than 42 weeks of gestation
number of weeks and days at delivery
次要结局
- proportion of patients with spontaneous preterm delivery before 34 weeks of gestation(at the end of study (maximum 1 year))
- Number of emergency visits(between initial admission and delivery (before 42 weeks of gestation))
- Neonatal morbidity(at the end of the study (1 year))
- Incidence of adverse events(1 year (end of study))
- Neonatal death(at the end of the study (1 year))
- Latency from admission to delivery(between initial admission and delivery (before 42 weeks of gestation))
- IL-6 levels in amniotic fluid and umbilical cord blood(delivery (maximum 42 weeks of gestational age))
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica