Buccal versus sublingual misoprostol alone for early pregnancy termination in legally restricted Latin American settings: A randomised trial
Wendy Sheldon1, Ilana Dzuba1, Heather Sayette2, Jill Durocher1, Beverly Winikoff1
1Gynuity Health Projects, New York, NY, USA, 2PP Global, New York, NY, USA
Objectives: To examine the efficacy and acceptability of two misoprostol only regimens that are commonly used for medical abortion in legally restrictive settings; as well as the feasibility of a multi-level pregnancy test (MLPT) for at-home follow-up.
Methods: This randomised open-label trial is ongoing at six clinics in two Latin American countries where abortion is highly restricted.* A total of 382 eligible, consenting women with gestations of ≤ 70 days who request medical abortion is required to show an expected difference of 8% in efficacy between the two study arms. Participants are randomised to three doses of buccal or sublingual administration of 800 mcg misoprostol every three hours. Study providers are blinded to group allocation. All women receive two MLPTs to administer and interpret abortion status: the first is taken in-clinic on the day of enrolment and the second at-home on the day of follow-up.
Results: Data collection should be completed before October 2016. To date, the overall rate of successful, non-surgical abortion is 93.4% (183/196) and rate of ongoing pregnancy is 1.0% (2/196). Among those with no ongoing pregnancy, the MLPT successfully identified this outcome in 83.5% (162/194) of cases; it also identified need for follow-up among all those with ongoing pregnancy (2/2). More than 80% (160/195) of participants stated they would select medical abortion in the future and 87.6% (170/194) felt they could use an MLPT on their own.
Conclusion: The efficacy of misoprostol alone is higher than expected based on published literature. Study findings will provide important evidence on the efficacy of a three-dose buccal misoprostol alone regimen. In addition, multi-level pregnancy tests appear to be a feasible and potentially useful tool for abortion service delivery in legally restrictive settings.
*Note: To protect study providers and their clinics, we are not disclosing country locations at this time.
Multi-level pregnancy test for medical abortion follow-up: what do we know so far?
Elizabeth Raymond, Tara Shochet, Jennifer Blum, Wendy Sheldon, Beverly Winikoff
Gynuity Health Projects, New York, NY, USA
Objectives: To summarise data on the effectiveness and feasibility of a strategy involving serial use of an urine multi-level pregnancy test (MLPT) for at-home follow-up after early medical abortion.
Methods: We included data from five published studies involving a total of 1,848 women who received treatment at ≤63 days of gestation. In all five studies, an MLPT with five hCG ranges was used for assessing medical abortion outcomes. A baseline test was administered just prior to mifepristone and a follow-up test was administered 1-2 weeks later. Declining hCG concentrations in successive tests were interpreted as indication of abortion success, while stable or increasing hCG concentrations were interpreted as indication of possible continuing pregnancy. The MLPT results were then compared with results from standard clinical assessment.
Result: A total of 93.8% (1487/1585) of those with successful abortion outcomes (no ongoing pregnancy) observed declining hCG concentrations in successive tests. All those with continuing pregnancies (21/21) observed stable or increasing hCG concentrations. The predictive value of the MLPT strategy for identifying continuing pregnancy was thus 100%. In addition, 94.0% (1496/1591) of women reported that the MLPT was either very easy or easy to use.
Conclusions: The MLPT strategy is highly successful at identifying continuing pregnancies as well as absence of continuing pregnancy. Use of this strategy is both feasible and effective and would reduce the need for clinic follow-up after medical abortion for the majority of women.
Alternative schemes for follow-up, including use of a semi-quantitative pregnancy test
Wendy Sheldon Gynuity Health Projects, New York, USA - firstname.lastname@example.org
Semi-quantitative urine pregnancy tests are a recent innovation with the potential to revolutionize abortion care worldwide. Sequential use of such tests enables women to monitor the success of their abortion procedures in the privacy of their own homes and can be an effective replacement for serum hCG and/or transvaginal ultrasound, thus reducing overall abortion-related costs and, for many women, the need to return for clinic-based follow-up. This presentation will summarize data from multiple studies conducted in the United States, Mexico, Tunisia and Vietnam using a semi-quantitative test with five bracketed hCG ranges (25-99, 100-499, 500-1,999, 2000-9,999, and 10,000 mIU/ml). The studies explore the effectiveness, feasibility and acceptability of using a semi-quantitative pregnancy test for at-home medical abortion follow-up at various points in time up until 14 days after initiation of the abortion procedure.