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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01186302
Eligibility Criteria:
Inclusion Criteria:
* Before randomization: Gestational age not more than 63 days as estimated by last menstrual period (LMP).
* After randomization: Gestational age not more than 63 days as estimated by abdominal and bimanual pelvic examination.
* Above national age of consent
* Willing to return to the clinic for misoprostol on Day 3 and for a follow-up visit on Day 10 to 14.
* Residence within the geographical area specified for each clinic and no more than one hour from emergency referral services.
* Willing to provide written informed consent to participate in the study and to be randomly assigned to a provider team.
* Able to understand the nature of the study, advice and instructions given by health providers.
Exclusion Criteria:
* Previous allergic reaction to one of the drugs in the medical abortion regimen
* Known or suspected ectopic pregnancy or undiagnosed adnexal mass
* Inherited porphyria (rare genetic blood diseases)
* Chronic adrenal failure
* Long term corticosteroid therapy
* Haemorrhagic disorder or anticoagulant therapy (blood thinner medications)
* IUD in utero that can not be removed before taking mifepristone
* Previous enrolment in the study (i.e. no repeat abortions; only one abortion per woman in the study)
* Unwilling or unable to return to clinic for follow-up visit.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT01186302
Study Brief:
Protocol Section:
NCT01186302