Home use of urine pregnancy tests for medical abortion follow-up

In The Lancet Global Health, Kirti Iyengar and colleagues1Iyengar K Paul M Iyengar SD et al.Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trial.Lancet Glob Health. 2015; 3: e537-e545Summary Full Text Full Text PDF Scopus (33) Google Scholar report findings from a randomised, controlled, non-inferiority trial in 731 women, which compared the effectiveness of standard clinic follow-up after medical abortion versus self-assessment with use of a low-sensitivity urine pregnancy test at home. The primary outcome was efficacy of the abortion procedure, defined as complete abortion without the need for additional clinical intervention within 30 days of study enrolment. The findings showed no significant differences between the two study groups: 95% of women in the home-assessment group reported having a complete abortion compared with 93% of women in the clinic follow-up group. This study addresses an important question about whether routine clinic follow-up after medical abortion can be responsively eliminated from service delivery protocols, thus reducing a key barrier to accessing medical abortion. Such a service change could be especially beneficial for women in rural, low-resource settings such as Rajasthan, India, where the study was done. The findings also underscore the high efficacy and safety of early medical abortion with a regimen of 200 mg mifepristone followed by misoprostol,2Raymond EG Shannon C Weaver MA et al.First trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review.Contraception. 2013; 87: 26-37Summary Full Text Full Text PDF PubMed Scopus (139) Google Scholar thus confirming that most women do not need clinic follow-up. Yet the investigators' main conclusion—that self-assessment of medical abortion at home with use of a low-sensitivity pregnancy test is as effective as clinic-based follow-up—seems premature, especially given that the primary outcome used in this study was efficacy of the abortion procedure. From a clinical perspective, the most important reason for using urine pregnancy tests after medical abortion is to identify possible cases of ongoing pregnancy that might otherwise go undetected in the short-term in absence of routine clinic follow-up. In recognition of this, several other studies on the same topic is detection of continuing pregnancy as the primary outcome,3Blum J Shochet T Lynd K et al.Can at-home semi-quantitative pregnancy tests server as a replacement for clinical follow-up of medical abortion? A US study.Contraception. 2012; 86: 757-762Summary Full Text Full Text PDF PubMed Scopus (51) Google Scholar, 4Lynd K Blum J Ngoc NT et al.Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up.Int J Gynaecol Obstet. 2013; 121: 144-148Summary Full Text Full Text PDF PubMed Scopus (27) Google Scholar, 5Ngoc NT Bracken H Blum J et al.Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial.Obstet Gynecol. 2014; 123: 88-95Crossref PubMed Scopus (41) Google Scholar, 6Michie L Cameron ST Simplified follow-up after early medical abortion: 12-month experience of a telephone call and self-performed low-sensitivity urine pregnancy test.Contraception. 2014; 89: 440-445Summary Full Text Full Text PDF PubMed Scopus (38) Google Scholar, 7Platais I Tsereteli T Comendant R et al.Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan.Contraception. 2015; 91: 178-183Summary Full Text Full Text PDF PubMed Scopus (20) Google Scholar, 8Cameron ST Glasier A Dewart H et al.Telephone follow-up and self-performed urine pregnancy testing after medical abortion: a service evaluation.Contraception. 2012; 86: 67-73Summary Full Text Full Text PDF PubMed Scopus (57) Google Scholar which is arguably the outcome of greatest importance in medical abortion follow-up given the need for its rapid and accurate recognition. In the study by Iyengar and colleagues, five continuing pregnancies were identified in the clinic follow-up group compared with two in the home-assessment group. Although these differences were not statistically significant, we cannot know for certain if some continuing pregnancies in the home-assessment group went undetected because of either human or test error, since most outcomes in this group were determined through the woman's self-report of her test results. Furthermore, since the study was primarily concerned with overall effectiveness of the abortion procedure, it was not powered to detect differences in incidence of ongoing pregnancy. Iyengar and colleagues are not the only researchers stymied by the practical and methodological complexities of assessing home follow-up after medical abortion. A study by Oppegaard and colleagues9Oppegaard KS Qvigstad E Fiala C et al.Clinical follow-up compared with self-assessment of outcome after medical abortion: a multicentre, non-inferiority, randomised, controlled trial.Lancet. 2015; 385: 698-704Summary Full Text Full Text PDF PubMed Scopus (57) Google Scholar that compared standard clinic follow-up versus home assessment with a semi-quantitative pregnancy test also selected the effectiveness of the abortion procedure as the primary outcome. In this study of 924 women in four European countries, complete abortion was reported to be 94% in women in the self-assessment group compared with 95% in the clinic follow-up group. These results led to a finding of non-inferiority despite the fact that none of three continuing pregnancies in the self-assessment group were detected by the test. In the study by Iyengar and colleagues no additional continuing pregnancies were subsequently identified after women had exited the study. However, this outcome could have been a result of challenges in maintaining contact with study participants in the rural, low-literacy setting in which this study was done. Yet both studies affirm the safety of home assessment after medical abortion. In both cases, the incidence of adverse events such as haemorrhage, infection, or hospital admission was not any higher in women with home follow-up than in those with routine clinic follow-up. The discrepancy in primary outcomes used to investigate home assessment with urine pregnancy tests after medical abortion ultimately raises the question of what information is most essential—both for research and clinical purposes. Although the detection of continuing pregnancy is a crucial outcome that requires additional clinical intervention and could otherwise go undetected in the short term, perhaps assurance that all continuing pregnancies will always be detected through home use of urine pregnancy tests is not an essential prerequisite for elimination of the routine follow-up visit, or for the provision of high-quality medical abortion care. Indeed, all continuing pregnancies will eventually be detected and most pose no health risks to women in the meantime. The WHO has already come to this conclusion in its most recent abortion guidelines,10WHOSafe abortion: technical and policy guidance for health systems. World Health Organization, Geneva2012http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdfGoogle Scholar which stipulate that routine clinical follow-up is not needed after medical abortion, and that repeat hCG testing can be used to confirm a complete outcome. Maybe it is time to go one step further by removing routine follow-up requirements of any sort from medical abortion service delivery protocols, bolstered in part by knowledge from studies, such as that by Iyengar and colleagues, which confirm the effectiveness of the medical abortion procedure and the ability of women to safely determine themselves when and if clinic follow-up is needed. I declare no competing interests. Self-assessment of the outcome of early medical abortion versus clinic follow-up in India: a randomised, controlled, non-inferiority trialHome assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting. Full-Text PDF Open Access