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A point-of-care urine test to predict adverse maternal and neonatal outcomes in Asian women with suspected preeclampsia

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

Abstract

Objectives

To assess clinical utility of the urine Congo red dot test (CRDT) in predicting composite adverse maternal and neonatal outcomes in women with suspected preeclampsia (PE).

Methods

CRDT result and pregnancy outcomes were prospectively documented in women with new onset or pre-existing hypertension, new or pre-existing proteinuria, PE symptoms and suspected PE-related fetal growth restriction or abnormal Doppler presenting from 20 weeks’ gestation between January 2020 and December 2022. Participants and clinicians were blinded to the CRDT result and managed according to internally agreed protocols. Composite maternal outcome was defined as PE, postpartum hemorrhage, intensive care unit admission, and maternal death. Composite neonatal outcome was defined as small for gestational age, preterm birth, 5-min Apgar score < 7, neonatal intensive care unit admission, and neonatal death.

Results

Two hundred and forty-four women out of two hundred and fifty-one (97.2%) had a negative CRDT. All seven women with positive CRDT had both adverse maternal and neonatal outcomes, giving positive predictive values (PPV) of 100%. Rates of composite adverse maternal and neonatal outcomes in CDRT negative women were 103/244 [42.2%, 95% confidence interval (CI) 36.2%–48.5%] and 170/244 (69.7%, 95% CI 63.6%–75.1%), respectively. CRDT negative predictive values (NPV) for adverse maternal and neonatal outcomes were, respectively, 141/244 (57.8%, 95% CI 48.6%–68.2%) and 74/244 (30.3%, 95% CI 23.8%–38.1%).

Conclusion

CRDT had low NPV but high PPV for adverse maternal and neonatal outcomes in women with suspected PE. Its role in clinical management and triage of women with suspected PE is limited as it cannot identify those at low risk of developing adverse outcomes.

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Data Availability

The dataset generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We wish to thank the members of the Obstetrics and Gynecology team, Maternal Fetal Medicine team, midwives, nurses, research students, and assistants at the Prince of Wales Hospital in facilitating the performance of this study. We also wish to thank PerkinElmer Inc. and Shuwen Biotech Co. Ltd. for providing the Congo red dot test kits free of charge.

Funding

The study was supported by grants from the Health and Medical Research Fund (HMRF Project No. 08191526), the Ministry of Science and Technology (MOST), China (No. 2021YFC2701600) and the Faculty of Medicine, The Chinese University of Hong Kong. The funding organizations played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Faculty of Medicine, Prince of Wales Hospital, 1/F Special Block E, Shatin, Hong Kong, China

    Natalie K. L. Wong, Isabella Y. M. Wah, Sani T. K. Wong, Long Nguyen-Hoang, Caitlyn S. L. Lau, Patricia N. P. Ip, Hillary H. Y. Leung, Daljit S. Sahota & Liona C. Poon

Authors
  1. Natalie K. L. Wong
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  2. Isabella Y. M. Wah
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  3. Sani T. K. Wong
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  4. Long Nguyen-Hoang
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  5. Caitlyn S. L. Lau
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  6. Patricia N. P. Ip
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  7. Hillary H. Y. Leung
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  8. Daljit S. Sahota
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  9. Liona C. Poon
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Contributions

The authors contributed to the study as listed below. NKLW: project development, data collection, data analysis, manuscript writing. IYMW: project development, data collection, manuscript editing. STKW: project development, data collection, data analysis. LN-H: data collection, data analysis. CSLLAU: data collection. PNPIP: data collection. HHYL: data collection. DSS: project development, data collection, data analysis, manuscript editing. LCP: project development, data collection, data analysis, manuscript editing. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Daljit S. Sahota or Liona C. Poon.

Ethics declarations

Ethical approval

Research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration, and has been approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (CREC Ref No: 2019.484).

Consent to participate

Written informed consent was obtained from all individuals included in this study.

Conflict of interest

LC Poon has received speaker fees and consultancy payments from Roche Diagnostics and Ferring Pharmaceuticals. In addition, she has received in-kind contributions from Roche Diagnostics, PerkinElmer, Thermo Fisher Scientific, and GE Healthcare. DS Sahota has received in-kind contributions from PerkinElmer, BRAHMS Thermo Fisher Scientific. Other authors report no conflict of interest.

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Wong, N.K.L., Wah, I.Y.M., Wong, S.T.K. et al. A point-of-care urine test to predict adverse maternal and neonatal outcomes in Asian women with suspected preeclampsia. Arch Gynecol Obstet (2023). https://doi.org/10.1007/s00404-023-07257-5

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