Efficacy of a low-sensitivity urine pregnancy test for identifying ongoing pregnancy after medication abortion at 64 to 70 days of gestation

Objectives: We assessed whether a low-sensitivity pregnancy test is effective at identifying ongoing pregnancy after medication abortion at 64 to 70 days of gestation.Study design: From October 2018 to March 2020, we performed a prospective observational study of participants in England and Wales undergoing medication abortion. Participants were scheduled to return to the clinic 14 +/- 3 days after mifepristone administration to perform a low-sensitivity pregnancy test (human chorionic gonadotropin threshold of 10 0 0 mIU/mL) and symptom checklist, and state whether they thought the abortion was complete. Clinicians also assessed the low-sensitivity pregnancy test and performed an ultrasound to determine abortion status. We calculated the sensitivity, specificity, negative and positive predictive value of the low-sensitivity pregnancy test (with and without a symptom checklist) for detecting ongoing pregnancy.Results: We enrolled 757 participants. Thirty-one did not progress to abortion and 558 (76.9%) completed follow-up. Most (79.6%) attended per-protocol; 22 (3.9%) attended earlier than 11 days and 92 (16.5%) later than 17 days. Thirteen participants (2.3%) had an ongoing pregnancy. The low-sensitivity pregnancy test correctly identified all the ongoing pregnancies (sensitivity = 100%; specificity = 84.8%; negative predictive value = 100%; positive predictive value = 13.5%). The symptom checklist alone had a sensitivity of 76.9% and a negative predictive value of 99.4% for identifying ongoing pregnancies. Participants and clinicians agreed on the interpretation of the low-sensitivity pregnancy test 94.6% of the time. Conclusions: Patient self-assessment of a low-sensitivity pregnancy test after medication abortion between 64-and 70 days' gestation has high sensitivity and negative predictive value for identification of ongoing pregnancy.Implications: Patients can be offered a low-sensitivity pregnancy test to assess for ongoing pregnancy after medication abortion up to 70 days of gestation thereby reducing the need for in-person visits. Services should be prepared to provide in-person assessments after positive or inconclusive results to ensure early identification of abortion complications.(c) 2022 Elsevier Inc. All rights reserved.