OBJECTIVE-The objectives of the study was to determine whether salivary progesterone (P) or estriol (E3) concentration at 16-20 weeks' gestation predicts preterm birth or the response to 17α-hydroxyprogesterone caproate (17OHPC) and whether 17OHPC treatment affected the trajectory of salivary P and E3 as pregnancy progressed.STUDY DESIGN-This was a secondary analysis of a clinical trial of 17OHPC to prevent preterm birth. Baseline saliva was assayed for P and E3. Weekly salivary samples were obtained from 40 women who received 17OHPC and 40 who received placebo in a multicenter ran-domized trial of 17OHPC to prevent recurrent preterm delivery.RESULTS-Both low and high baseline saliva P and E3 were associated with a slightly increased risk of preterm birth. However, 17OHPC prevented preterm birth comparably, regardless of baseline salivary hormone concentrations. 17OHPC did not alter the trajectory of salivary P over pregnancy, but it significantly blunted the rise in salivary E3 as well as the rise in the E3/P ratio.
NIH Public AccessAuthor Manuscript Am J Obstet Gynecol. Author manuscript; available in PMC 2009 December 16. Published in final edited form as: Am J Obstet Gynecol. 2008 November ; 199(5): 506.e1-506.e7. doi:10.1016/j.ajog.2008.003.
NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript CONCLUSION-17OHPC flattened the trajectory of E3 in the second half of pregnancy, suggesting that the drug influences the fetoplacental unit.
Keywords17-alpha-hydroxyprogesterone caproate; longitudinal studies; preterm birth; salivary estriol; salivary progesterone Progesterone has long been recognized as necessary for pregnancy maintenance, and the role of progesterone withdrawal in the initiation of labor in animal species has been known for decades. 1 However, the role of progesterone withdrawal, as measured by plasma progesterone concentration or the ratio of progesterone/estrogens, in the initiation of normal labor in humans or other primates is unclear. 2-4 Nevertheless, there is evidence that functional progesterone withdrawal caused by changes such as reduction in progesterone receptors 5 or relative increase in the progesterone receptor (PR)-A progesterone receptor isoform, which blocks PR-B isoform-mediated gene transcription 6 may trigger labor in humans. We are unaware of any study that has assessed the ability of measurement of salivary progesterone, which is representative of the biologically active unbound fraction in plasma or serum, 7 to predict preterm birth.In 2 recent randomized clinical trials, injections of 17-α-hydroxyprogesteronecaproate (17OHPC) 8 or vaginal suppositories containing progesterone 9 reduced the recurrence or occurrence of preterm birth among high-risk women. Because 17-α-hydroxyprogesterone is produced by the normal placenta in amounts greater than the doses administered in these clinical trials 10 and because normal plasma progesterone concentrations are 9 times higher than those of 17-α-hydroxyprogesterone 11 and greater than the dissociation c...