Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT03600857
Eligibility Criteria:
Inclusion Criteria:
* Women aged \>/= 18 years requesting a termination of pregnancy, for social, medical or foetal indications
* gestational age 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,
* general good health,
* single intra-uterine pregnancy,
Exclusion Criteria:
* do not wish to participate or unable to communicate in Swedish or English.
* non-viable pregnancy (confirmed by ultrasonography).
* 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).
* any pre-existing health conditions for whom the execution of a medical abortion as judged by the investigator could compromise their condition (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) or a duplex pregnancy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03600857
Study Brief:
Protocol Section:
NCT03600857