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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02342002
Eligibility Criteria:
Inclusion Criteria:
* Ultrasound examination demonstrating:
1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
* If fetus exists, fetal size less than 12 weeks+6 days
* Closed cervical os
* Eligible to consent for research according to local regulations
Exclusion Criteria:
* Active bleeding at enrollment and/or history of bleeding within the prior week
* Allergies or other contraindications to the use of mifepristone or misoprostol
* Suspected ectopic pregnancy
* History of trophoblastic disease
* Coagulation disorder and/or currently taking anticoagulants
* Any serious medical condition
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02342002
Study Brief:
Protocol Section:
NCT02342002