Gynuity Health Projects

Programs

Multi-level Pregnancy Test

Overview

The multi-level pregnancy test (MLPT) is a five-bracketed immunochromatographic assay panel that operates as both a high sensitivity and a low sensitivity measure of hCG, the pregnancy hormone. It provides readings of five thresholds: at least 25, at least 100, at least 500, at least 2000, and at least 10,000 mIU/mL. The test offers a technical improvement over other urine pregnancy tests in that it provides information about the trend in hCG levels. The test can be performed and read in under 20 minutes by women at home or by clinicians in a medical setting.

The MLPT can be used to monitor trends in hCG levels over time, both increasing and decreasing levels. In normal pregnancies, hCG levels double every 48 – 72 hours, peaking at 8 – 11 weeks of pregnancy and then declining for the remainder of the pregnancy. Following medical abortion, a decrease in hCG level can be used to confirm a successful abortion. For women undergoing fertility treatment, the test could be used to monitor hCG levels and document an increase in hCG.

MLPT for medical abortion follow-up

Common medical abortion practice includes clinic-based follow-up with assessment, often including transvaginal ultrasound, to determine each woman’s abortion status. This follow-up visit can be costly and time consuming for both the health care system and women. As medical abortion becomes more widely used, many women simply do not return to the clinic to receive a clinician’s confirmation of complete abortion. Providing women with a safe, effective and affordable at-home diagnostic tool to confirm if a pregnancy is ongoing after administration of mifepristone and misoprostol could reduce costs and simplify the procedure by limiting the number of clinic visits, costly exams and waiting time. Ideally, a woman could receive abortion drugs, a pregnancy test (MLPT), and counseling on how to manage her abortion at home at her initial clinic visit. She would also be given guidelines for following-up with the clinic if needed. With these tools, the majority of women could manage their abortion follow-up at home.

Gynuity has been exploring the efficacy and acceptability of using the MLPT at home 1-2 weeks following medical abortion in the US, Vietnam, and Moldova & Uzbekistan. In these studies, the MLPT was used at the time the woman took the mifepristone (to establish a baseline) and then on the morning of standard medical abortion follow-up, which was one week after mifepristone in the U.S. and two weeks after mifepristone in the other three countries. The MLPT was highly successful in identifying ongoing pregnancy at one and two weeks post-mifepristone. Of the 2,505 uses and 32 ongoing pregnancies, only 1 ongoing pregnancy was reported as not identified at home with the test, and that woman later self-identified. Approximately 90% of all women felt that the test was easy or very easy to use.

If the multi-level pregnancy test could be successfully used even earlier post treatment, this would constitute an important service delivery improvement: it would shorten the duration of the procedure by 3– 10 days. A shorter procedure is generally preferable to women, and earlier follow-up would likely help reduce lost-to-follow up rates in some settings. One current study explores whether the MLPT would be able to document a decline in hCG level sufficiently to provide similar sensitivity and sensitivity to a 7-day follow-up. The results could lay the groundwork for streamlined medical abortion care worldwide by shortening the duration of the procedure and reducing the number of additional clinic visits required for each medical abortion client.

MLPT for use in fertility treatment

In both high and low-income settings, assisted fertility care entails numerous clinic visits, lab tests and ultrasounds, often at high cost to the woman. Standard monitoring protocols after embryo transfer or (intrauterine insemination (IUI) include continuous sequential pregnancy tests, serum hCG analyses and ultrasound – all done on a regular (at times weekly) basis in a clinic setting. The MLPT could be incorporated into existing models of care for use as an outpatient tool to help women: 1) ascertain initial presence of the pregnancy hormone hCG, and 2) monitor hCG level to confirm that it is increasing appropriately in the early weeks after embryo transfer or IUI. Monitoring with an MLPT promises to be less costly for the woman and health care system. Also, it may allow the woman to know earlier if she has a growing pregnancy as serial testing at home could begin earlier and be more frequent than current clinic-based monitoring protocols. Gynuity is conducting pilot studies to examine the feasibility and acceptability of using an MLPT at home to help monitor pregnancy progress during assisted fertility treatment.

Gynuity Activities
  • Studies to explore the efficacy and acceptability of using the MLPT following medical abortion to identify ongoing pregnancy
  • Studies to examine the utility of using the MLPT at home following fertility treatment to assist in monitoring pregnancy progress