Clinical trial: Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study (NCT04687189)

Eligibility criteria:
Inclusion Criteria:

          -  Women between the ages of 18 and 38 inclusive

          -  Women with BMI up to 40

          -  Women able to freely give consent electronically, given COVID. For the purposes of
             this study, this is defined as women who speak native or fluent English; and have a
             high school degree or equivalent, and who are otherwise, in the professional judgement
             of the PI, able to give informed consent

          -  N = 30 will be recruited from the general population, e.g., no known previous issues

          -  N = 15 will be positive controls with submucosal fibroids

          -  Women who are in driving distance from Boston (including Vermont and Connecticut);
             these states are covered by the PI's medical license during the COVID emergency

          -  Women between cycle days 3 and 10 at the time of testing; or IUD users who do not have
             a menses

        Exclusion Criteria:

          -  Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists,
             OB/GYNs, Reproductive Endocrinologists

          -  Women with BMI over 40

          -  Women who do not speak English natively or fluently

          -  Women who have recently given birth, and have had fewer than 3 postpartum menstrual
             cycles

          -  Women who have recently had a stillbirth or abortion more than 20 weeks (subject to
             the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks
             are subject to two wait cycles

          -  Women who are currently pregnant or may be pregnant

          -  Any woman the PI believes is not capable of giving independent, informed consent

          -  Turtle Health employees
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 38 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? Contradiction