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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT07174856
Eligibility Criteria:
Inclusion Criteria:
* Pregnancy of \< or = 77 days duration based on LMP or ultrasound
* Positive pregnancy test (self-report or in-clinic)
* Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older
* Willing and able to give informed consent
* Willing to comply with study protocol
* Willing to record requested information in the study surveys
* English or Spanish speaking
* Has a text message, email, or phone call capable device for survey completion
* Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization
Exclusion Criteria:
* concurrent participation in any other interventional trial
* unwilling to comply with the study protocol and survey/visit schedule
* contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
* contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
* cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
* diagnosis of porphyria
* known bleeding disorder or receiving anticoagulants
* pregnancy with an IUD in place
* diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and/or open cervical os)
* possibility of ectopic pregnancy
* known or suspected pelvic infection
* Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
* Have previously participated in the study
* Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Study:
NCT07174856
Study Brief:
Protocol Section:
NCT07174856