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Vaginal progesterone vs cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis - 21/12/12

Doi : 10.1016/j.ajog.2012.10.877 
Agustin Conde-Agudelo, MD, MPH a, Roberto Romero, MD, DMedSci a, Kypros Nicolaides, MD b, Tinnakorn Chaiworapongsa, MD a, c, John M. O'Brien, MD d, Elcin Cetingoz, MD e, Eduardo da Fonseca, MD f, George Creasy, MD g, Priya Soma-Pillay, MD h, Shalini Fusey, MD i, Cetin Cam, MD e, Zarko Alfirevic, MD j, Sonia S. Hassan, MD a, c
a Perinatology Research Branch, NICHD/NIH/DHHS, Bethesda, MD, and Detroit, MI 
b Department of Obstetrics and Gynecology, King's College Hospital, London, UK 
c Wayne State University/Hutzel Hospital, Detroit, MI 
d Perinatal Diagnostic Center, Central Baptist Hospital, and the Department of Obstetrics and Gynecology, University of Kentucky, Lexington, KY 
e Department of Obstetrics and Gynecology, Zeynep Kamil Women and Children Diseases Education and Research Hospital, Uskudar, Istanbul, Turkey 
f Departamento de Obstetrícia e Ginecologia, Hospital do Servidor Publico Estadual “Francisco Morato de Oliveira” and School of Medicine, University of São Paulo, São Paulo, Brazil 
g Columbia Laboratories, Inc, Livingston, NJ 
h Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, and the University of Pretoria, Pretoria, South Africa 
i Department of Obstetrics and Gynecology, Government Medical College and Hospital, Maharashtra, India 
j University of Liverpool, Liverpool, UK 

Résumé

Objective

No randomized controlled trial has compared vaginal progesterone and cervical cerclage directly for the prevention of preterm birth in women with a sonographic short cervix in the mid trimester, singleton gestation, and previous spontaneous preterm birth. We performed an indirect comparison of vaginal progesterone vs cerclage using placebo/no cerclage as the common comparator.

Study Design

Adjusted indirect metaanalysis of randomized controlled trials.

Results

Four studies that evaluated vaginal progesterone vs placebo (158 patients) and 5 studies that evaluated cerclage vs no cerclage (504 patients) were included. Both interventions were associated with a statistically significant reduction in the risk of preterm birth at <32 weeks of gestation and composite perinatal morbidity and mortality compared with placebo/no cerclage. Adjusted indirect metaanalyses did not show statistically significant differences between vaginal progesterone and cerclage in the reduction of preterm birth or adverse perinatal outcomes.

Conclusion

Based on state-of-the-art methods for indirect comparisons, either vaginal progesterone or cerclage are equally efficacious in the prevention of preterm birth in women with a sonographic short cervix in the mid trimester, singleton gestation, and previous preterm birth. Selection of the optimal treatment needs to consider adverse events, cost and patient/clinician preferences.

Le texte complet de cet article est disponible en PDF.

Key words : birthweight, cervix, neonatal intensive care unit, perinatal mortality, perinatal morbidity, premature, prematurity, progestin, 17⍺-hydroxyprogesterone caproate, 17P


Plan


 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, Bethesda, MD.
 Most of the authors report no conflict of interest, except as stated in this paragraph. J.M.O. was involved in studies of progesterone gel treatment for preterm birth prevention sponsored by Columbia Laboratories, Inc (which is the manufacturer of the preparation used in the PREGNANT trial) and a previous trial of vaginal progesterone in women at risk for preterm delivery, serves on advisory boards, and is a consultant for Watson Pharmaceuticals (which is 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 Number 7,884,093: Progesterone for the Treatment and Prevention of Spontaneous Preterm Birth). G.C. is an employee of Columbia Laboratories, Inc.
 Reprints not available from the authors.
 Cite this article as: Conde-Agudelo A, Romero R, Nicolaides K, et al. Vaginal progesterone vs cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis. Am J Obstet Gynecol 2013;208:42.e1-18.


© 2013  Publié par Elsevier Masson SAS.
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Vol 208 - N° 1

P. 42.e1-42.e18 - janvier 2013 Retour au numéro
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