Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII). - APOSTEL VIII

Amsterdam UMC location AMC0 个研究点目标入组 760 人开始时间: 2017年7月6日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•Women = 18 years old with a singleton or twin pregnancy with a gestational age between 30 0/7 and 33 6/7 weeks with threatened preterm birth defined by regular uterine contractions, and one of the following:
•- Cervical length of < 15 mm or
•- Cervical length of 15-30 mm and a positive fFn test or in case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test
•- Ruptured amniotic membranes
•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 760
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- Previous treatment for threatened preterm birth with corticosteroids in current pregnancy.
•- Contra indication for tocolysis
•- Signs of fetal distress
•- Signs of intra uterine infection
•- Fetal chromosomal or severe congenital abnormalities

发起方

Amsterdam UMC location AMC