Association Between Vaginal Progesterone Use and Risk of Preterm Birth Among High-Risk Pregnancies: A Real-World Evidence Study
Author(s)
Xi Wang, PhD, Djeneba Audrey Djibo, MS, PhD, Cheryl N. Walraven, PhD;
CVS Health, Blue Bell, PA, USA
CVS Health, Blue Bell, PA, USA
Presentation Documents
OBJECTIVES: In 2022, the preterm birth rate in the United States was 10.4%, higher than the rate in most developed countries. Previous randomized control trials have found conflicting results on the efficacy of vaginal progesterone in preterm birth prevention. This study aims to evaluate the association between receipt of vaginal progesterone during pregnancy and the risk of preterm birth among pregnancies at high risk for preterm birth, using real-world data.
METHODS: A retrospective study was conducted among pregnancies to people who enrolled in a large national commercial health plan with non-administrative services only (non-ASO) health insurance, had a live birth outcome during 2016-2024, continuously enrolled in medical and drug benefits during pregnancy, and were at high risk for preterm birth due to cervix shortening, history of preterm labor, or multiple gestations. Pregnancies with any progesterone other than vaginal progesterone, such as medroxyprogesterone and hydroxyprogesterone, were excluded. A comparable unexposed group was identified through propensity score matching (PSM).
RESULTS: This study included 6198 pregnancies that were at high risk for preterm birth. Among them, 294 (4.7%) received vaginal progesterone during pregnancy (the exposed group). The PSM identified 294 pregnancies without vaginal progesterone as the unexposed group that had similar distributions on all covariates, including demographic factors (age, race/ethnicity) and clinical factors (cervix shortening, history of preterm labor, multiple gestation, smoking, existing/gestational diabetes or hypertension, and placenta previa). The rate of preterm birth was 33.7% in the exposed group and 30.3% in the matched unexposed group, resulting in a risk difference of 3.4% with a 95% confidence interval of -4.1% to 10.9%.
CONCLUSIONS: In a sample of commercially insured pregnancies that were at high risk for preterm birth, there was no evidence of an association between vaginal progesterone use and risk of preterm birth.
METHODS: A retrospective study was conducted among pregnancies to people who enrolled in a large national commercial health plan with non-administrative services only (non-ASO) health insurance, had a live birth outcome during 2016-2024, continuously enrolled in medical and drug benefits during pregnancy, and were at high risk for preterm birth due to cervix shortening, history of preterm labor, or multiple gestations. Pregnancies with any progesterone other than vaginal progesterone, such as medroxyprogesterone and hydroxyprogesterone, were excluded. A comparable unexposed group was identified through propensity score matching (PSM).
RESULTS: This study included 6198 pregnancies that were at high risk for preterm birth. Among them, 294 (4.7%) received vaginal progesterone during pregnancy (the exposed group). The PSM identified 294 pregnancies without vaginal progesterone as the unexposed group that had similar distributions on all covariates, including demographic factors (age, race/ethnicity) and clinical factors (cervix shortening, history of preterm labor, multiple gestation, smoking, existing/gestational diabetes or hypertension, and placenta previa). The rate of preterm birth was 33.7% in the exposed group and 30.3% in the matched unexposed group, resulting in a risk difference of 3.4% with a 95% confidence interval of -4.1% to 10.9%.
CONCLUSIONS: In a sample of commercially insured pregnancies that were at high risk for preterm birth, there was no evidence of an association between vaginal progesterone use and risk of preterm birth.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO87
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Reproductive & Sexual Health