Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up

Abstract

Objective: To simplify follow-up after medical abortion by examining whether women could use a semiquantitative pregnancy test at home to screen for ongoing pregnancy. Methods: Three hundred women seeking medical abortion at a tertiary hospital in Vietnam participated in the study. Participants used a semiquantitative pregnancy test at the hospital to estimate baseline human chorionic gonadotropin (hCG) levels and administered another test at home 2 weeks later for comparison. Women interpreted the test result at home and then returned to hospital for follow-up care. At this visit, self-assessment was verified. To assess further the feasibility of the test as a follow-up tool in service delivery, 200 additional women completed a user comprehension survey. Results: The tests identified all 11 ongoing pregnancies among study participants (100% sensitivity; 89.7% specificity). Women reported that the test was easy to use (255/292 [87.3%]) and that provider instructions helped them to use the test (291/292 [99.7%]). Conclusion: Semi-quantitative pregnancy tests offer high sensitivity and negative predictive value. If user instructions can be further simplified, the tests could be used in lieu of transvaginal ultrasound and/or serum hCG at clinic-based follow-up or by women themselves for home-based follow-up. Clinical trials.gov: NCT01150279

A research agenda for moving early medical pregnancy termination over the counter

“…Although ongoing pregnancy occurs <1% of the time with mifepristone and misoprostol ≤10 weeks of gestation, there is ongoing investigation into how best to identify these women, whether it be symptom‐based or by use of semi‐quantitative4, 31, 32 or low‐sensitivity2, 3 urine pregnancy tests. The critical step for safely self‐using medical termination is understanding when to seek medical care, both for signs and symptoms of ongoing pregnancy as well as for complications such as bleeding and infection, and documenting that they are able to do so.…”

Assessment of completion of early medical abortion using a text questionnaire on mobile phones compared to a self-administered paper questionnaire among women attending four clinics, Cape Town, South Africa

“…12 Recent research suggests that a set of questions or a symptom checklist combined with an appropriate pregnancy test may be the best strategy for out-of-clinic self-assessment of abortion outcome. 7,16,19,20 For out-of-clinic self-assessment the importance of timely identification of ongoing pregnancies is obvious. In the South African public sector, second trimester abortion services are only available in a small number of secondary and tertiary hospitals and the services are overbooked and difficult for women to access.…”

“…In addition, studies have shown that as medical abortion with mifepristone and misoprostol becomes better known and is further demedicalized,* women increasingly don't return to the clinic if they consider the procedure to have been complete. 7,8 Tracing women by telephone who have not returned for follow-up, in order to reassure providers that treatment has been successful, can be time consuming 9 and may not be feasible in resource-constrained settings like the South African public sector (Personal communication, regional health manager, 2010).…”

“…17,18 Studies exploring safe self-assessment methods have included a set of questions on the symptoms experienced plus different pregnancy tests. 7,8,19 A 2012 review of the evidence 20 pointed towards a symptom checklist combined with a suitable pregnancy test as the most promising method to accurately self-assess ongoing pregnancies, complications or incomplete procedures.…”

“…Also, before 2013, many of these studies had been conducted in developed countries; only recently has limited evidence been emerging from low-and middle-income settings. 7,10 The purpose of this study was to determine whether women could complete an accurate selfassessment of the outcome of medical abortion on their mobile phones while at home. We aimed to assess the accuracy of the mobile assessment in predicting the provider's assessment of the need for manual vacuum aspiration or additional misoprostol at follow-up; we also compare these results to results using the same self-assessment done on paper at the women's follow-up clinic visit.…”