Clinical trial: Very Early Medical Abortion (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.
Female
Accepts Healthy Volunteers
Subject must be at least 16 Years old.


Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0