EUCTR2016-003603-61-BE进行中（未招募）1 期
Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betamethasone (12 mg) in 24 hours apart, to decrease the risk of respiratory distress syndrome at the newborn children - CORTGEM 2
未提供0 个研究点目标入组 50 人开始时间: 2017年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Sign inform consent
- •2.Normal twin pregnancy
- •3.Mother’s age between 18 and 40 years old
- •4.Premature delivery risk based on cardiotocography analysis (> 6 contractions/30 minutes) with open cervix (> 1 cm) on digital examination and/or ultrasound cervical length < 25 mm
- •5.Treatment with Atosiban
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Medical contra-indication for tocolysis (mother or fetus)
- •2.Fetal distress based on the cardiotocography and/or ultrasound
- •3.Contra-indication to corticoid (infection)
- •4.Other treatment with corticoid (local or general)
- •5.Previous administration of corticoids for lung maturation in this pregnancy
- •6.Diabetes mellitus with insulin therapy
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