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Serial Salivary Estriol to Detect an Increased Risk of Preterm Birth

From the University of Pittsburgh, Pittsburgh, Pennsylvania, the University of Colorado Health Sciences Center, Denver, Colorado, the University of Southern California, Los Angeles County, Los Angeles, California, the State University of New York, Syracuse, New York, the University of Michigan, Ann Arbor, Michigan, the University of California, San Francisco, California, and the University of Utah, Salt Lake City, Utah.

Address reprint requests to: R. Phillip Heine, MD Magee Womens Hospital—University of Pittsburgh Department of Obstetrics and Gynecology 204 Craft Avenue, Room 530 Pittsburgh, PA 15213 E-mail: rsirph{at}mail.magee.edu

Objective: To evaluate serial measurements of salivary estriol (E3) to detect increased risk of spontaneous preterm labor and preterm birth.

Methods: A masked, prospective, multicenter trial of 956 women with singleton pregnancies was completed at eight United States medical centers. Saliva was collected weekly, beginning at the 22nd week of gestation until birth, and tested for unconjugated E3 by enzyme-linked immunosorbent assay. Women were separated into high-risk and low-risk groups using the Creasy scoring system.

Results: A single, positive (at or above 2.1 ng/mL) salivary E3 test predicted an increased risk of spontaneous preterm labor and delivery in the total population (relative risk [RR] 4.0, P < .005), in the low-risk population (RR 4.0, P .05), and in the high-risk population (RR 3.4, P = .05). Two consecutive positive tests significantly increased the RR in all study groups, with a dramatic improvement in test specificity and positive predictive value but only a modest decrease in sensitivity. In women who presented with symptomatic preterm labor, salivary E3 identified 61% of those who delivered within 2 weeks, using a threshold of 1.4 ng/mL.

Conclusion: Elevated salivary E3 is associated with increased risk of preterm birth in asymptomatic women and symptomatic women who present for evaluation of preterm labor.

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