Observational studyBMC pregnancy and childbirth2017
Comparison of rapid immunoassays for rupture of fetal membranes.
Observational study in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
Maternal Serum Levels of Selected Trace Elements and Heavy Metals in Pregnancies Complicated With Preterm Prelabor Rupture of Membranes
Who cites it
5 citing papers in PubMed, 23 citations in OpenAlex.
- GalNAc in vaginal secretions: a potential non-invasive risk indicator associated with the risk of premature rupture of membranes.PloS one · 2025Article
- Current and Emerging Strategies for Prediction and Diagnosis of Prelabour Rupture of the Membranes: A Narrative Review.The Malaysian journal of medical sciences : MJMS · 2021Review
- Middle-East OBGYN Graduate Education (MOGGE) Foundation Practice Guidelines: Prelabor rupture of membranes; Practice guideline No. 01-O-19.Journal of global health · 2020Article
- The Prevalence and Payer Costs of Potentially Avoidable Emergent Care Visits for Suspected Amniotic Membrane Rupture in Pregnant Women.American health & drug benefits · 2018Article
- Cytokines in Preterm Delivery: Proposal of a New Diagnostic Algorithm.Journal of immunology research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRupture of membranes (ROM) before the onset of uterine contractions, particularly in pregnancies less than 37 weeks gestational age, is a common diagnostic problem in obstetrical practice. Timely detection of ROM is vital to support gestational age-specific interventions to optimize perinatal outcomes and minimize the risk of serious complications such as preterm delivery, fetal distress and maternal/fetal infections. Rapid bedside immunoassay tests designed to detect amniotic fluid proteins in cervicovaginal fluids have emerged as valuable clinical tools to provide timely ROM diagnosis.
methodsIn this prospective observational study, two commercially-available immunoassay tests (ROM Plus®, AmniSure®) were evaluated concurrently in 111 pregnant women who presented with the chief complaint of ROM. Immunoassay results were compared to clinical parameters for determining ROM via comprehensive, retrospective clinical chart review. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy.
resultsOverall, diagnostic performance characteristics were robust and similar between ROM Plus® and AmniSure®, respectively: sensitivity (96.4 and 89.3%), specificity (98.8 and 100%), PPV (96.4 and 100%), NPV (98.8% and 96.5) and accuracy (98.2 and 97.3%). For term patients (≥37 weeks gestation), the sensitivities were 93.8 and 81.3% and specificities were 97.1 and 100% for ROM Plus® and AmniSure®, respectively. For preterm patients (<37 weeks gestation), both immunoassay tests provided exact concordance with clinical confirmation of ROM resulting in 100% diagnostic accuracy.
conclusionsBoth rapid immunoassay tests provided similarly excellent diagnostic accuracy for the rapid detection of ROM with only two discrepant results for ROM Plus® and three discrepant results for AmniSure® compared to clinical confirmation. The findings from this study recommend these tests for pregnant women presenting with suspected ROM to guide correct clinical management decisions to improve obstetrical and neonatal outcomes.
trial registrationClinicalTrials.gov, NCT02208011 (1 August 2014).
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Registered trials
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