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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

  • Roberto Romero
  • , Kypros Nicolaides
  • , Agustin Conde-Agudelo
  • , Ann Tabor
  • , John M. O'Brien
  • , Elcin Cetingoz
  • , Eduardo Da Fonseca
  • , George W. Creasy
  • , Katharina Klein
  • , Line Rode
  • , Priya Soma-Pillay
  • , Shalini Fusey
  • , Cetin Cam
  • , Zarko Alfirevic
  • , Sonia S. Hassan

Research output: Contribution to journalArticlepeer-review

484 Scopus citations

Abstract

Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (≤25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality. Study Design: Individual patient data metaanalysis of randomized controlled trials. Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0.58; 95% confidence interval [CI], 0.420.80), <35 weeks (RR, 0.69; 95% CI, 0.550.88), and <28 weeks (RR, 0.50; 95% CI, 0.300.81); respiratory distress syndrome (RR, 0.48; 95% CI, 0.300.76); composite neonatal morbidity and mortality (RR, 0.57; 95% CI, 0.400.81); birthweight <1500 g (RR, 0.55; 95% CI, 0.380.80); admission to neonatal intensive care unit (RR, 0.75; 95% CI, 0.590.94); and requirement for mechanical ventilation (RR, 0.66; 95% CI, 0.440.98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies. Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.

Original languageEnglish
Pages (from-to)124.e1-124.e19
JournalAmerican Journal of Obstetrics and Gynecology
Volume206
Issue number2
DOIs
StatePublished - Feb 2012

Funding

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.

Funders
National Institutes of Health (NIH)
U.S. Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health and Human Development

    Keywords

    • 17α-hydroxyprogesterone caproate
    • admission to neonatal intensive care unit
    • birthweight <1500 g
    • mechanical ventilation
    • prematurity
    • preterm birth
    • progestin
    • respiratory distress syndrome
    • transvaginal ultrasound
    • uterine cervix

    ASJC Scopus subject areas

    • Obstetrics and Gynecology

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