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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT03989869
Eligibility Criteria:
Inclusion Criteria:
1. Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks
2. No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
3. Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
4. Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up
5. Capable of giving their informed consent to participate.
Exclusion Criteria:
1. Women with visible (confirmed) IUP
2. Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
3. Inability to give informed consent.
The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66):
1. Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.
2. Not confirmed IUP: This group includes cases where:
1. ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or
2. ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT03989869
Study Brief:
Protocol Section:
NCT03989869