Clinical trial: Comparative Effectiveness of Pregnancy Failure Management Regimens (NCT02012491)

Eligibility criteria:
Inclusion Criteria:

          -  between 5 and 12 completed weeks gestation

          -  18 years or older

          -  hemodynamically stable

          -  confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation
             (ultrasound examination demonstrates a fetal pole without cardiac activity measuring
             between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy
             failure)

          -  willing and able to give informed consent

        Exclusion Criteria:

          -  diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active
             bleeding, open cervical os)

          -  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)

          -  most recent hemoglobin <9.5 g/dL

          -  diagnosis of porphyria

          -  known clotting defect or receiving anticoagulants

          -  pregnancy with an intrauterine device (IUD) in place

          -  breastfeeding during the first 7 days of study participation

          -  unwilling to comply with the study protocol and visit schedule

          -  any evidence of viable pregnancy

          -  possibility of ectopic pregnancy

          -  known or suspected pelvic infection

          -  concurrent participation in any other interventional trial
Female
No healthy subjects accepted to join the trial.
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