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

Dr. Charles Lockwood

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.

Citation:

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
DOI: http://dx.doi.org/10.1016/S0140-6736(16)00350-0

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Dr. Charles J. Lockwood (2016). Vaginal Progesterone Did Not Prevent Preterm Death or Delivery MedicalResearch.com

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