American Journal of Obstetrics and Gynecology
Reports of major impactVaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data
Section snippets
Materials and Methods
The study was conducted based on a prospectively prepared protocol, and is reported using the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines for metaanalyses of randomized controlled trials142 and suggested guidelines for IPD metaanalyses.141
Study selection, details, and quality
The searches yielded 2611 citations, of which 10 were considered for potential inclusion (Figure 1). Five studies were excluded.125, 153, 154, 155, 156 Three of these studies evaluated vaginal progesterone in women at high risk for preterm birth (previous preterm birth,125, 154 uterine malformation,125 cervical insufficiency,125 and twins155) but none of them measured or collected data on cervical length. Two of these studies125, 154 reported that prophylactic administration of vaginal
Principal findings of this study
Vaginal progesterone administration to asymptomatic women with a sonographic short cervix in the midtrimester was associated with: (1) a significant 42% reduction in the rate of preterm birth <33 weeks (primary outcome); (2) a significant reduction in the risk of preterm birth <35, <34, <30, and <28 weeks and a trend for a reduction in the rate of preterm birth <36 weeks; (3) a significant reduction in the risk of spontaneous preterm birth <33 and <34 weeks; (4) a significantly lower rate of
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The majority of the authors report no conflict of interest except as stated in this paragraph. J.M.O'B. was involved in studies of progesterone gel treatment for preterm birth prevention sponsored by Columbia Laboratories Inc, the manufacturer of the preparation used in the PREGNANT Trial and a previous trial of vaginal progesterone in women at risk for preterm delivery. J.M.O'B. serves on advisory boards and is a consultant for Watson Pharmaceuticals, a company with a financial interest in marketing vaginal progesterone gel for the prevention of preterm birth. He and others are listed in the patent on the use of all progesterone compounds to prevent preterm birth (US Patent No. 7,884,093: Progesterone for the Treatment and Prevention of Spontaneous Preterm Birth). G.W.C. is an employee of Columbia Laboratories Inc.
This research was supported, in part, by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services.
Reprints not available from the authors
Cite this article as: Romero R, Nicolaides K, Conde-Agudelo A, et al. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 2012;206:124.e1-19.