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Randomized Controlled Trial
. 2008 Nov;199(5):506.e1-7.
doi: 10.1016/j.ajog.2008.03.003. Epub 2008 May 23.

Salivary progesterone and estriol among pregnant women treated with 17-alpha-hydroxyprogesterone caproate or placebo

Mark A Klebanoff  1 , Paul J Meis, Mitchell P Dombrowski, Yuan Zhao, Atef H Moawad, Allison Northen, Baha M Sibai, Jay D Iams, Michael W Varner, Steve N Caritis, Mary J O'Sullivan, Kenneth J Leveno, Menachem Miodovnik, Deborah Conway, Ronald J Wapner, Marshall Carpenter, Brian M Mercer, Susan M Ramin, John M Thorp, Alan M Peaceman; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
Collaborators, Affiliations
Randomized Controlled Trial

Salivary progesterone and estriol among pregnant women treated with 17-alpha-hydroxyprogesterone caproate or placebo

Mark A Klebanoff et al. Am J Obstet Gynecol. 2008 Nov.

Abstract

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 17alpha-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 randomized 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.

Conclusion: 17OHPC flattened the trajectory of E3 in the second half of pregnancy, suggesting that the drug influences the fetoplacental unit.

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Figures

FIGURE 1
FIGURE 1. Preterm birth by treatment (17P/placebo) and baseline salivary progesterone and estriol percentiles
Klebanoff. Salivary progesterone and estriol among pregnant women treated with 17-α-hydroxyprogesterone caproate or placebo. Am J Obstet Gynecol 2008.
FIGURE 2
FIGURE 2. Weekly values of salivary progesterone, estriol, and the progesterone/estriol ratio according to treatment group
Weekly values of salivary progesterone (A), estriol (B), and the progesterone/estriol ratio (C) according to treatment group. P value for difference in slope between drug- and placebo-treated women = .38 for progesterone, .013 for estriol, and .003 for progesterone/estriol ratio. Klebanoff. Salivary progesterone and estriol among pregnant women treated with 17-α-hydroxyprogesterone caproate or placebo. Am J Obstet Gynecol 2008.
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