JPRN-UMIN000013518已完成未知
A Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Study Assessing Efficacy of Progesterone Vaginal Tab for Prevention of Preterm Delivery - Trial Of Progesterone vaginal tab In prevention of preterm delivery evaluated by CervicAl Length (TROPICAL Study)
Japan Society of Premature Birth0 个研究点目标入组 119 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 119
研究概览
简要总结
o significant differences in the frequency of women with a cervical length 20 mm at 34 weeks of gestation were observed between both groups. All preterm births occurred after 34 weeks of gestation, except for one patient in the placebo group. The progesterone group had a lower rate of preterm birth before 37 weeks than the placebo group (3.4% vs. 15.0%, respectively; p < .05).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1) Pregnant women younger than 20 years old when consent is provided (2) Women with multiple pregnancy (3) Pregnant women with preterm premature rupture of membranes (pPROM) (4) Pregnant women with genital haemorrhage (5) Pregnant women with abnormality of fetuses or other fetal appendages (fetal structural anomaly, fetal dysfunction, dysgenesis, placenta praevia, premature separation of normally implanted placenta, single umbilical cord artery, polyhydramnios, oligohydramnios, and so on) (6) Pregnant women who have already underwent cervical cerclage for current pregnancy (7) Pregnant women who started any other treatment for threatened premature labour such as tocolytic agents (8) Pregnant women with severe hepatic function disorder, renal impairment, cardiac disease and others (9) Pregnant women who underwent cervical conization (10) Pregnant women who became pregnant through in vitro fertilization or embryo transfer (11) Pregnant women who used progesterone agents for the current pregnancy (12) Pregnant women who cannot insert vaginal tabs on their own (13) Pregnant women with allergy to progesterone agents (14) Pregnant women from who understanding of this study cannot be obtained (15) Other pregnant women when study doctors conclude that they are not eligible for study enrollment
研究者
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