NCT02132533已完成3 期
Nifedipine for Acute Tocolysis of Preterm Labor
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of Participants With Preterm Birth
研究概览
简要总结
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.
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
- 16 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 16 and 44 years of age inclusive
- •Singleton pregnancy
- •Intact membranes
- •Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
- •Reported or documented uterine activity
- •Cervical dilation between 2 cm and 4 cm inclusive
排除标准
- •Multifetal gestation
- •Less than 28 weeks' gestation
- •34 or more weeks' gestation
- •Ruptured membranes
- •More than 4 cm dilated
- •Previously received a course of corticosteroids for fetal lung maturation
- •Oligohydramnios
- •Fetal growth restriction
- •Chorioamnionitis or temperature of at least 38.0 degrees Celsius
- •Fetal death
- •Preeclampsia
- •Suspected placental abruption or placenta previa
- •Lethal fetal malformation or amniotic fluid index at least 35
- •Systolic BP < 90 mmHg or diastolic BP < 50 mmHg
- •Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)
- •Chronic hypertension treated with antihypertensives in pregnancy
- •Seizure disorder or HIV
- •Maternal allergy to nifedipine
- •Known maternal cardiac disease
- •Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth
研究组 & 干预措施
Nifedipine
Experimental
Women with preterm labor will receive nifedipine.
干预措施: Nifedipine (Drug)
Nifedipine
Experimental
Women with preterm labor will receive nifedipine.
干预措施: Usual care (Other)
Placebo
Experimental
Women with preterm labor will receive placebo.
干预措施: Placebo (Drug)
Placebo
Experimental
Women with preterm labor will receive placebo.
干预措施: Usual care (Other)
结局指标
主要结局
Number of Participants With Preterm Birth
时间窗: Less than 37 weeks of gestation
次要结局
- Number of Participants With Preterm Birth(Within 7 days of randomization)
研究者
研究点 (1)
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