Objective.The Amnisure ROM™ test is approved for the diagnosis of rupture of membranes ROM. Yet, a fraction of patients with a positive test have intact membranes by sterile speculum examination. The objective of this study was to determine the clinical significance of this finding. Methods.The study population consisted of four groups of nulliparous women at term: 1 not in labor without clinical evidence of ROM n 125; 2 in labor without clinical ROM with a negative Amnisure test™ n 56; 3 in labor without clinical ROM with a positive Amnisure test™ n 25; and 4 in labor with clinical ROM n 30. The Amnisure test™ was performed in cases without clinical ROM Groups 1, 2 and 3. Results.1 The Amnisure test™ was positive more frequently in women in labor with intact membranes than in patients not in labor at term without ROM 30.9 2581 women vs. 4.8 6125 women; p < 0.001; 2 patients in labor without clinical ROM with a positive Amnisure test™ had a significantly shorter admission-to-delivery interval than those in labor without clinical ROM with a negative Amnisure test™ p < 0.05. Conclusion.1 A positive Amnisure test™ is present in about one-third nulliparous women at term presenting in labor with intact membranes; 2 patients with a positive Amnisure test™ had a shorter admission-to-delivery interval than those with a negative test.
Bibliographical noteFunding Information:
This research was supported in part by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS. The Amnisure ROM testTM (the placental a-microglobulin-1 immunoassay) kits were provided free of charge by the Korean supplier of N-Dia Inc. (New York, NY). N-Dia Inc. did not contribute funds towards this study. None of the authors own any stock in this company and are either current or former employees of this company or are members of a speaker’s bureau for this company.
All Science Journal Classification (ASJC) codes
- Pediatrics, Perinatology, and Child Health
- Obstetrics and Gynaecology