Tocolytic Therapy for Preterm Labor in Multiple Gestation
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 主要终点
- Duration of labor
研究概览
简要总结
To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.
详细描述
Preterm birth remains the principal cause of early neonatal death. Infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. Moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. Patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm.
A number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. To date, only atosiban is in use outside of clinical trials. Atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. Early reports of the use of Atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Twin pregnancy
- •Gestational age between 24+0 and 32+6 weeks
- •Intact amniotic membranes
- •Threatened preterm labor
排除标准
- •Rupture of membranes
- •Vaginal bleeding resulting from placenta previa or placental abruption
- •Fever above 38°C
- •Severe preeclampsia
- •Maternal cardiovascular or liver diseases
- •Systolic blood pressure less than 90 mm Hg
- •Known uterine malformation
- •Intrauterine growth restriction below the fifth percentile
- •Non-reassuring fetal status
- •Antepartum diagnosis of major fetal malformations
- •Fetal death
- •Previous tocolytic therapy or Betamethasone treatment
研究组 & 干预措施
Atosiban
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Atosiban group.
干预措施: Atosiban (Drug)
Nifedipine
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Nifedipine group.
干预措施: Nifedipine (Drug)
结局指标
主要结局
Duration of labor
时间窗: 48 hours
次要结局
- Chronic lung disease(28 days)
- Infant morbidity(28 days)