Clinical trial: The Role of a Semi-Quantitative Urine Pregnancy Test and Pregnancy Questionnaire After Uterine Evacuation for Undesired Pregnancy of Uncertain Location (NCT01596972)

Eligibility criteria:
Inclusion Criteria:

          -  Women aged 18 years or older with an undesired pregnancy < 6 weeks gestation

          -  Women with a positive urine pregnancy test

          -  Proficiency in English

          -  Working phone and subject willing to be contacted by phone.

          -  Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction
             with assigned follow-up method

        Exclusion Criteria:

          -  Women with presence of a yolk sac or crown rump length visualized on ultrasound

          -  Women with a gestational sac greater than 13mm [11]

          -  High Suspicion for ectopic pregnancy

             o Sign: Concerning adnexal mass seen on ultrasound in conjunction with pelvic pain
             and/or vaginal spotting

          -  Hemodynamic instability

             o Signs: heavy vaginal bleeding, hypotension, tachycardia

          -  Pelvic Infection

             o Signs: pain or fever

          -  Medical conditions that contraindicate uterine evacuation according to PPLM clinic
             policy

             o These include but are not limited to: a bleeding disorder or anticoagulation,
             significant cardiac disease, renal or liver failure, IUD in situ that cannot be
             removed

          -  Unwilling or unable to comply with study follow-up procedures

          -  Being in a situation where receiving phone calls or additional contact with research
             staff may endanger the privacy or safety of the subject (e.g. situations of domestic
             violence or abuse)

          -  Inability to give informed consent

          -  Previous participation in this study
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? Entailment