Rupture of membranes self-assessment

ABSTRACT

Objective: An accurate tool to self-assess rupture of membranes (ROM) could decrease the need for hospital visits during the COVID pandemic. Our objectives were to evaluate the agreement between patients’ and researchers’ interpretation of a test for ROM using a modified FDA approved device and to evaluate patients’ level of difficulty interpreting the test. Study Design: A prospective cohort study of women complaining of leakage of fluid at ≥20 weeks gestation. Women wore sanitary pads with a modified lateral flow alpha-fetoprotein immunoassay strip to detect ROM. The strip was obtained from the FDA approved ROM Plus kit (Laborie/Clinical Innovations). Another set of pads was instilled with their urine. Patients and investigators interpreted the tests as positive (2 bars), negative (1 control bar), and other (not activated [no bars] or invalid [partial or unclear bars]). Cohen’s kappa was used to measure the agreement between patients and researchers. Difficulty interpreting the test was graded by patients on a scale of 1-10 (1 = least difficult, 10 = most). Results: Twenty-one women were recruited 19 had ROM confirmed by clinical assessment, and 2 had ROM ruled out. Fifty-four pads were tested (women could wear more than 1 pad). Of the 26 worn by women with confirmed ROM, 20 (76.9%) were positive, none (0%) were negative, 3 [11.5%] were invalid and 3 [11.5%] were not activated. Of the 24 urine instilled pads from women with confirmed ROM, 4 (16.7%) were positive, 18 (75%) were negative and 2 (8.3%) were not activated. The women with ROM ruled out had non-activated tests (2 dry worn pads) and their urine instilled on 2 additional pads showed negative results. Cohen’s kappa was 0.85.Weighted kappa 0.88. The mean level of difficulty interpreting the test was 1.64. Conclusion: The modification of the FDA approved test did not result in false positive or negative results and 81.5% gave definitive results. Patients and researchers had a near perfect agreement interpreting the test. Women can easily interpret this self-test. [Formula presented] [Formula presented]