Salivary estriol as risk assessment for preterm labor: A prospective trial

OBJECTIVE: Increased understanding of human parturition allows for novel approaches to (1) identification of women at increased risk for preterm birth and (2) development and controlled testing of etiology-based strategies to prevent preterm birth. STUDY DESIGN: Five hundred forty-two women were enrolled at five study sites in a prospective evaluation of salivary estriol in samples obtained weekly beginning at 22 weeksʹ gestation (Salest, Biex, Inc., Boulder, Colo.). Estriol concentrations wre determined with a well-characterized enzyme-linked immunoassay. Women adjudged at either high risk or low risk for prematurity were evaluated through to delivery. RESULTS: A total of 267 women submitted serial samples that were analyzed; 241 women with singleton pregnancies submitted sufficient samples. Twenty-three women with singleton fetuses went into idiopathic preterm labor (without prior rupture of membranes) and were delivered preterm (mean 35 weeksʹ gestation); 182 were delivered at term (>-37 weeksʹ gestation). Mean (geometric) estriol concentrations were higher from 24 to 34 weeks in women with singleton pregnancies delivering preterm (p< 0.05). A surge in estriol concentrations occurred approximately 3 weeks before the onset of labor in both women delivering at term and those delivering preterm. This increase occurred approximately 4 weeks earlier in women delivered preterm versus term. Receiver-operator curve analyses showed that exceeding a 2.3 ng/ml saliva estriol level was associated with occurrence of preterm labor (71% sensitivity, 77% specificity, 23% false-positive rate). CONCLUSION: Detection of an early estriol surge or increased level (≥2.3 ng/ml) may be clinically helpful in identifying women at elevated risk for preterm labor and birth, allowing for evaluation of biologically based interventions in controlled trials.