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Placental α-microglobulin-1 to detect uncertain rupture of membranes in a European cohort of pregnancies

  • Materno-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

We evaluated the performance of the placental alpha-microglobulin-1 immunoassay (AmniSure®, AT) in cervicovaginal secretions in patients with uncertain rupture of membranes (ROM) and investigated the influence of the examiners experience.

Methods

This prospective cohort study was performed in pregnant women (17–42 weeks of gestation) with signs of possible ROM. Evaluation included clinical assessment, examination for cervical leakage, Nitrazine test and measurement of the amniotic fluid index by ultrasound and AT. ROM occurrence was based on review of the medical records after delivery.

Results

199 women were included. AT had a sensitivity of 94.4%; specificity of 98.6%; positive predictive value, 96.2%; negative predictive value, 98.0%. Clinical assessment showed a sensitivity of 72.2%; specificity of 97.8%; positive predictive value, 92.9%; negative predictive value, 90.6%. AT was more sensitive for diagnosing ROM (p = 0.00596) compared to clinical assessment, independent of the examiners experience. Furthermore, the sole use of AT reduced costs by 58.4% compared to clinical assessment.

Conclusions

AT was more sensitive compared to clinical assessment, independent of the examiners experience and gestational age. Our data extend its use in patients with uncertain ROM. Moreover, AT seems to be a cost-effective approach in the assessment of these patients.

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Acknowledgments

The AmniSure ROM test™ kits were provided free of charge by Pro Concepta AG, Zug, Switzerland. Pro Concepta AG did not contribute any further funding for this study. We thank A. Schötzau for expert statistical assistance and D.J. Huang for proof reading the manuscript.

Conflict of interest

None.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, University Hospital Basel, University of Basel, Spitalstr. 21, 4031, Basel, Switzerland

    Ariane Birkenmaier, Jean-Jacques Ries, Olav Lapaire & Irene Hösli

  2. Neurology and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland

    Jens Kuhle

  3. Department of Obstetrics and Gynaecology, Kantonsspital Liestal, Liestal, Switzerland

    Nicole Bürki

Authors
  1. Ariane Birkenmaier
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  2. Jean-Jacques Ries
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  3. Jens Kuhle
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  4. Nicole Bürki
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  5. Olav Lapaire
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  6. Irene Hösli
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Corresponding author

Correspondence to Irene Hösli.

Additional information

O. Lapaire and I. Hösli contributed equally to this work.

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Birkenmaier, A., Ries, JJ., Kuhle, J. et al. Placental α-microglobulin-1 to detect uncertain rupture of membranes in a European cohort of pregnancies. Arch Gynecol Obstet 285, 21–25 (2012). https://doi.org/10.1007/s00404-011-1895-9

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  • DOI: https://doi.org/10.1007/s00404-011-1895-9

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