Fetus-Placenta-Newborn
The Preterm Prediction Study: Toward a multiple-marker test for spontaneous preterm birth,☆☆

https://doi.org/10.1067/mob.2001.116752Get rights and content

Abstract

Objective: The Preterm Prediction Study evaluated 28 potential biologic markers for spontaneous preterm birth in asymptomatic women at 23 to 24 weeks gestational age. This analysis compares those markers individually and in combination for an association with spontaneous preterm birth at <32 and <35 weeks gestational age. Study Design: With the use of a nested case-control design from an original cohort study of 2929 women, results of tests from 50 women with a spontaneous preterm birth at <32 weeks and 127 women with a spontaneous preterm birth at <35 weeks were compared with results from matched-term control subjects. Results: In the univariate analysis, the most potent markers that are associated with spontaneous preterm birth at <32 weeks by odds ratio were a positive cervical-vaginal fetal fibronectin test (odds ratio, 32.7) and <10th percentile cervical length (odds ratio, 5.8), and in serum, >90th percentiles of α-fetoprotein (odds ratio, 8.3) and alkaline phosphatase (odds ratio, 6.8), and >75th percentile of granulocyte colony-stimulating factor (odds ratio, 5.5). Results for spontaneous preterm birth at <35 weeks were generally similar but not as strong. Univariate and multivariate logistic regression analyses demonstrated little interaction among the tests in their association with spontaneous preterm birth. Combinations of the 5 markers were evaluated for their association with <32 weeks spontaneous preterm birth. Ninety-three percent of case patients had at least 1 positive test result versus 34% of control subjects (odds ratio, 24.0; 95% CI, 6.4-93.4). Among the case patients, 59% had ≥2 positive test results versus 2.4% of control subjects (odds ratio, 56.5; 95% CI, 7.1-451.7). If a cutoff of 3 positive test results was used, 20% of case patients and none of the control subjects had positive test results (P <.002). With the use of only the 3 serum tests (alkaline phosphatase, α-fetoprotein, and granulocyte colony-stimulating factor), any positive test identified 81% of cases versus 22% of control subjects (odds ratio, 14.7; 95% CI, 5.0-42.7). For spontaneous preterm birth at <35 weeks gestation, any 2 positive tests identified 43% of cases and 6% of control subjects (odds ratio, 11.2; 95% CI, 4.8-26.2). Conclusion: Overlap among the strongest biologic markers for spontaneous preterm birth is small. This suggests that the use of tests such as maternal serum α-fetoprotein, alkaline phosphatase, and granulocyte colony-stimulating factor as a group or adding their results to fetal fibronectin test and cervical length test results may enhance our ability to predict spontaneous preterm birth and that the development of a multiple-marker test for spontaneous preterm birth is feasible. (Am J Obstet Gynecol 2001;185:643-51.)

Section snippets

Methods

The relationship between spontaneous preterm birth and many of the individual markers that were evaluated at 23 to 24 weeks in the Preterm Prediction Study have been presented previously.4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Because of the large number of women in the original cohort (n = 2929), the large number of potential tests to be studied, and their costs, we originally planned to complete a nested case-control study of the tests after the major outcomes (such as

Results

Tables I and II show each of the factors included in the case-control analysis, the source of data or fluid from which the measurement was made, the cutoff value for a positive test, the percent of test results that were positive in the case patients and in the control subjects, and the crude odds ratio for spontaneous preterm birth at <32 weeks (Table I) and at <35 weeks (Table II).

. Risk factors and tests for spontaneous preterm birth at <32 weeks obtained or available at 24 weeks’ gestational

Comment

To date, the potential benefits in improving pregnancy outcome by predicting spontaneous preterm birth have not been realized, principally because we have few, if any, effective interventions that can be used once high-risk status has been identified.2 As an example, it is now reasonably clear that the use of the demographic screening tests that focus on age, race, workload, and previous pregnancy outcomes, when used to identify women for various additional testing or interventions such as more

Acknowledgements

The authors acknowledge the participation of the following institutions and others who participated in the study: The University of Alabama at Birmingham (Rachel L. Copper, MSN, CRNP; John C. Hauth, MD; Allison Northen, RN); Wake Forest University (Allison Frye, RN; Eberhard Mueller-Heubach, MD; Melissa Swain, RN); University of Chicago (Phyllis Jones, MPH, RN; Marshall Lindheimer, MD); University of Cincinnati (Nancy Elder, MSN, RN; Tariq A. Siddiqi, MD); George Washington University, The

References (26)

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Supported by the following grants from the National Institute of Child Health and Human Development (NICHD): HD21410, HC21414, HC21434, HD27860, HD27861, HD27869, HD27883, HD27889, HD27905, HD27915, HD27917, and HD19897.

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