Clinical trial: Medical Abortion for Emergency Contraception Failure (NCT00677755)

Eligibility criteria:
Inclusion Criteria:

          -  Participants included in the study were women aged 16 years or older

          -  with good general health,

          -  experiencing a mifepristone emergency contraception failure,

          -  presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan,
             with a crown-rump length compatible within 56 days of gestation at the enrolled day,
             and

          -  seeking a medical abortion for unwanted pregnancy.

          -  Women who had a threatened abortion or a failure pregnancy were also included.

          -  Participants were required to sign an informed consent form before enrolment, willing
             to comply with the schedule of follow-up visits and willing to undergo surgical
             aspiration if indicated.

        Exclusion Criteria:

          -  The exclusion criteria included suspected or proven ectopic pregnancy,

          -  allergy or contraindications for mifepristone (chronic systemic corticosteroid
             therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe
             asthma, glaucoma, sickle cell anemia and hypotension),

          -  history or evidence of thromboembolism, cardiovascular disease or liver disease,
             hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day),

          -  presence of an intrauterine device, and breastfeeding.

          -  Other exclusion criteria included participants who had EC failure because incorrect
             use, for example, having further unprotected intercourse after EC.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 40 Years

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