11 Mar Vaginal Progesterone Did Not Prevent Preterm Death or Delivery
MedicalResearch.com Interview with:
Charles J. Lockwood, MD
Member of of the March of Dimes Board of Trustees
Dean at Morsani College of Medicine
Senior Vice President, USF Health and Professor of Obstetrics & Gynecology, and Public Health The University of South Florida
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Lockwood: There remain questions about the utility of vaginal progesterone therapy in asymptomatic women with singleton gestations at risk for preterm birth. The OPPTIMUM study investigators conducted a double-blind, randomized, placebo-controlled trial of vaginal progesterone delivered via a pessary releasing 200 mg per day (n=618) vs. placebo (n=610) from around 22 to 34 weeks gestation among women at high risk for prematurity on the basis of a characteristic history and/or the presence of cervicovaginal fetal fibronectin or a cervical length less than 25 mm in length on transvaginal ultrasound. The primary endpoints were fetal death or preterm birth before 34 weeks (obstetrical outcome), or a composite of neonatal mortality or morbidities (neonatal outcome). The authors found that progesterone had no significant impact on either primary endpoint, with an adjusted OR of 0·86, 95% CI: 0·61-1·22 for obstetrical outcomes and an OR of 0·62, 95% CI:0·38-1·03 for neonatal outcomes.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Lockwood: I do not believe that this study should change current recommendations for the use of weekly intramuscular 17 alpha-hydroxyprogesterone caproate (17P) injections from 16 weeks gestation among women with a history of prior spontaneous preterm birth. The OPPTIMUM study did not employ 17P and initiated therapy later in gestation (22 to 24 weeks) in a far higher risk population as manifested by cervical change or excess fetal fibronectin release. Moreover, given that meta-analyses of prior studies suggest a benefit to vaginal progesterone in women with incidentally found short cervices at mid-gestation, coupled by the lack of power in the OPPTIMUM study to definitively exclude a reduction in adverse neonatal outcomes accruing vaginal progesterone, I would not recommend abandoning the use of vaginal progesterone in asymptomatic women with incidentally observed midtrimester cervical shortening, if that is your current practice.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Lockwood: Cleary additional large randomized trials of vaginal progesterone among women in various categories of preterm birth risk are needed to definitively confirm or rule-out efficacy.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial
Norman, Jane Elizabeth et al.
The Lancet , Volume 0 , Issue 0
Published Online: 23 February 2016
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Dr. Charles J. Lockwood (2016). Vaginal Progesterone Did Not Prevent Preterm Death or Delivery MedicalResearch.com