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Accuracy of a combined insulin-like growth factor-binding protein-1/interleukin-6 test (Premaquick) in predicting delivery in women with threatened preterm labor

  • George Uchenna Eleje , Euzebus Chinonye Ezugwu , Ahizechukwu Chigoziem Eke , Lydia Ijeoma Eleje , Joseph Ifeanyichukwu Ikechebelu , Ifeanyichukwu Uzoma Ezebialu , Chukwudi Celestine Obiora , Betrand Obi Nwosu , Chukwuemeka Okwudili Ezeama , Gerald Okanandu Udigwe , Charles Ikechukwu Okafor and Frank Okechukwu Ezugwu
Published/Copyright: February 25, 2017

Abstract

Purpose:

To determine values of combinations of interleukin-6 (IL-6)/cervical native insulin-like growth factor-binding protein-1 (IGFBP-1)/total IGFBP-1 (Premaquick©) in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in women with threatened preterm labor.

Methods:

Women with singleton pregnancies between gestation age (GA) of 24 weeks and 36 weeks and 6 days with preterm labor were recruited during a prospective multicenter study. Premaquick© was positive when at least two of three biomarkers were positive. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were estimated for both prediction of spontaneous deliveries and spontaneous exclusive preterm deliveries.

Results:

Ninety-seven (99.0%) out of 98 women enrolled were analyzed. Based on delivery status 7/14 days post-enrollment of general study population, Premaquick© had a sensitivity of 87.1/85.7%, a specificity of 92.4/96.8%, a PPV of 84.4/93.8% and a NPV of 93.9/92.3% for prediction of spontaneous delivery. Predictive accuracy of Premaquick© test in relation to days of enrollment were: 90.7% (≤7 days) and 92.8% (≤14 days). For women enrolled at GA <35 weeks, Premaquick© had a sensitivity of 100.0/87.5%, a specificity of 94.1/96.9%, a PPV of 70.5/87.5%, a NPV of 100.0/96.9% and an accuracy of 95.0/95.0% for prediction of preterm delivery within 7/14 days of enrollment, respectively. PPV was most significantly different in both groups when outcomes were compared between 2 days and 14 days post-enrollment (P<0.001).

Conclusion:

This novel triple biomarker model of native and total IGFBP-1 and IL-6 appears to be an accurate test in predicting spontaneous deliveries and spontaneous exclusive preterm deliveries in threatened preterm labor in singleton pregnancies.


Corresponding author: Dr. George Uchenna Eleje, Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi Campus, P.M.B. 5025, Nnewi, Anambra State, Nigeria, Tel.: +2348068117444, E-mail:

Acknowledgments

We thank the participants, the primary care midwives along with the resident doctors, obstetricians and other staff of the participating hospitals for their help with patient recruitment and data collection. The authors wish to thank Biosynex SA for supporting the study including Dr. Thierry Paper, Deputy General Manager, Business Development, of Biosynex, France, for his kind support and free supply of the preterm labor test kits and other materials used in the study. Our thanks also go to Dr. Anne-Claire Andries for her assistance in data analysis.

  1. Disclaimer: Biosynex SA, which supported the study and supplied Premaquick© tests, did not get involved or participate in the study design, collection and manuscript development. None of the authors is an employee of, and/or holds stock in, Biosynex SA, France. Anne-Claire Andries helped in “uncertainty” statistical analysis.

Author’s statement

  1. Conflict of interest: Author GE received a financial support from Biosynex SA in order to present the preliminary result of this work as poster presentation at the French Obstetric Congress (College National des Gynecologues et Obstetriciens Francais) held in Montpellier, France on December 7–9, 2016. Other authors declare that they have no conflict of interest.

  2. Material and methods: Informed consent: Informed consent has been obtained from all individuals included in this study.

  3. Ethical approval: The research related to human subject use has complied with all the relevant national regulations, and institutional policies, and is in accordance with the tenets of the Helsinki Declaration, and has been approved by the authors’ institutional review board or equivalent committee.

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Received: 2016-10-24
Accepted: 2017-1-17
Published Online: 2017-2-25
Published in Print: 2017-11-27

©2017 Walter de Gruyter GmbH, Berlin/Boston

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