Clinical trial: Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation (NCT00330993)

Eligibility criteria:
Inclusion Criteria:Healthy females: 1) 18 years of age or older, 2) requesting an elective
        termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more
        than 63 days gestation on the day of mifepristone administration as documented by
        endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply
        with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if
        indicated, and 7) with easy and ready access to a telephone.

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        Exclusion Criteria:1) ultrasound evidence at the evaluation(s) prior to mifepristone
        treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy
        to mifepristone, chronic corticosteroid administration, adrenal disease), 3)
        contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly
        controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected
        extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7)
        known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina,
        valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy
        with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed
        endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report,
        14) prior participation in this research study, or 15) current participation in another
        research study that, in the opinion of the investigator, would interfere with the conduct
        of this study.

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Female
Accepts Healthy Volunteers
Subject must be at least 18 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? Contradiction