Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia

Abstract

BackgroundThis study was conducted to assess the efficacy and acceptability of using a multi-level pregnancy test (MLPT) combined with telephone follow-up for medical abortion in Tunisia, where the majority of providers are midwives.MethodsFour hundred and four women with gestational age ≤ 70 days’ LMP seeking medical abortion at six study sites were enrolled in this open-label trial. Participants administered a baseline MLPT at the clinic prior to mifepristone administration and were asked to take a second MLPT at home and to call in its results before returning the day of their scheduled follow-up visit 10-14 days later.ResultsAlmost all women with follow-up (97.1 %, n = 332/342) had successful abortions without the need for surgical intervention. The MLPT worked extremely well among women ≤63 days’ LMP in ruling out ongoing pregnancy (negative predictive value (NPV) =100 % (n = 298/298)) and also detecting women with ongoing pregnancies (sensitivity = 100 %; 2/2) as needing follow-up due to non-declining hCG. Among women 64-70 days’ LMP, the test also worked well in ruling out ongoing pregnancy (NPV = 96.9 % (n = 31/32) but not as well in terms of sensitivity (50 %), with only one of two ongoing pregnancies detected by MLPT as needing follow-up. Most women (95.1 %) found the MLPT to be very easy or easy to use and would consider using the MLPT again (97.4 %) if needed.ConclusionsSelf-administered pre and post MLPT are very easy for women to use and accurate in assessing medical abortion success up to 63 days’ LMP. MLPT use for medical abortion follow-up has the potential to facilitate task sharing services and eliminate the burden of routine in-person follow-up visits for the large majority of women. Additional research is warranted to explore the accuracy of the MLPT in identifying ongoing pregnancy among women with gestational ages > 63 days.Trial registrationThis study was registered on May 13, 2010, on clinicaltrials.gov as NCT01150279.

Use of an at‐home multilevel pregnancy test and an automated call‐in system to follow‐up the outcome of medical abortion

“…The current findings confirmed previous research showing that MLPTs are effective for identifying women with no ongoing pregnancy following medical abortion initiated on or before 63 days from the last menstrual period . The present study also corroborated published evidence suggesting that MLPT has potentially lower accuracy for detecting ongoing pregnancy following medical abortion performed after 63 days …”

“…Limitations of the present study included the small sample size; no ongoing pregnancies occurred among the women who had a medical abortion on or before 63 days, and we were thus unable to determine how the MLPT and IVR approach would perform in these infrequent cases. However, previous research shows that the MLPT is accurate in detecting ongoing pregnancy following medical abortion within that time frame, and it is unlikely that use of the IVR system would deter women from seeking additional care if the MLPT results indicated it was necessary. In addition, it was not possible to determine whether the participants had accurately reported their follow‐up MLPT results because women read the test and entered results into the IVR system at home and these data were not validated at the time of interpretation by the IVR system.…”

“…The outcome of medical abortion as indicated by the reported at‐home MLPT result versus the in‐clinic follow‐up evaluation was compared. After protocol development and ethical approval of the present study, the MLPT using the dBest test was shown to be potentially less predictive of ongoing pregnancy among women having medical abortion after 63 days compared to pregnancies greater than 63 days . Consequently, the results were stratified by duration of pregnancy from last menstrual period (≤63 days, 64–70 days).…”

“…The multilevel pregnancy test (MLPT) is a promising tool for streamlining the follow‐up of medical abortion . This semiquantitative test comprises a urine dipstick that provides bracketed ranges of human chorionic gonadotropin (hCG) levels.…”

“…Most studies assessing MLPTs in abortion care have used a two‐test before‐and‐after approach, whereby hCG range is determined both at baseline (i.e. before administration of mifepristone and misoprostol) and at 7–14 days later . If the hCG range has decreased during this time frame, women and healthcare providers can be confident of no ongoing pregnancy.…”