Clinical trial: Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion (NCT01943279)

Eligibility criteria:
Inclusion Criteria:

          1. Requests a medical abortion and fulfills standard eligibility criteria for M&M
             abortion:

               -  Clear decision to have an abortion

               -  Valid Ontario Health card

               -  Willing to abstain for vaginal intercourse and alcohol for 14 days

               -  Ability to insert misoprostol vaginal tablets

               -  Emergency Contact number

               -  Stop folic acid vitamins on initial contact

               -  Good general health

               -  Single intrauterine gestation less than or equal to 49 days as determined by
                  transvaginal ultrasound

               -  Telephone access

               -  Access to emergency medical care within 30 minutes of home

               -  Agrees to undergo a surgical abortion in case of failure of the medical abortion
                  method

          2. Ability to understand the protocol and consent

          3. Willingness to comply with either the SFU or RFU follow-up schedule

        Exclusion Criteria:

          1. Factors that exclude women from eligibility for M&M abortion:

               -  Coagulopathy or hemoglobin less than 100, White Blood Cell count < 4.0 platelet
                  <140,000

               -  Allergy to methotrexate or misoprostol

               -  Presence of an intrauterine device

               -  Acute or chronic renal or hepatic disease

               -  Acute inflammatory bowel disease

               -  Uncontrolled seizure disorder

               -  Sickle cell anemia

               -  Breastfeeding

               -  Chronic oral corticosteroid therapy

               -  Any condition that in the opinion of the clinician investigator would compromise
                  the safety of medical abortion for this patient

          2. Requires the support of an interpreter
Female
No healthy subjects accepted to join the trial.
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? Entailment