Medical termination of pregnancy from day 85 to day 153 of gestation: A randomized comparison between administration of the initial dose of misoprostol at home or in the clinic - PRIMA - Medical termination of II trimester pregnancy: a randomized trial

Karolinska Institutet0 个研究点目标入组 896 人开始时间: 2018年3月14日最近更新: 2018年12月4日

适应症

试验速览

暂无简介。

•Women aged >/= 18 years requesting a termination of pregnancy,
•the gestational age being determined to 85 – 153 days (with ultrasonography), willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language, in general good health, with a single intrauterine pregnancy, who have given their informed consent
•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 896
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Women who do not wish to participate or who are unable to communicate in Swedish or English. Women carrying a non-viable pregnancy (confirmed by ultrasonography).
•Women with a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication).
•Women with pre-existing health conditions in whom the execution of a medical abortion as judged by the investigator could compromise their condition will also be excluded. Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders.
•Fetal malformation that may impact time–to-expulsion (such as hydrocephalus, hydrops/edema).

发起方