Abstract:
Objective. To evaluate the efficacy of vaginal progesterone administration for preventing preterm birth and
perinatal morbidity and mortality in asymptomatic women with a singleton gestation and a mid-trimester sonographic cervical length (CL) < 25 mm.
Methods. This was an updated systematic review and meta-analysis of randomized controlled trials comparing the use of vaginal progesterone to placebo/no treatment in women with a singleton gestation and a mid-trimester sonographic CL < 25 mm. Electronic databases, from their inception to May 2016, bibliographies and
conference proceedings were searched. The primary outcome measure was preterm birth < 34 weeks of gestation
or fetal death. Two reviewers independently selected studies, assessed the risk of bias and extracted the data.
Pooled relative risks (RRs) with 95% confidence intervals (CI) were calculated.
Results. Five trials involving 974 women were included. A meta-analysis, including data from the OPPTIMUM study, showed that vaginal progesterone significantly decreased the risk of preterm birth < 34 weeks of
gestation or fetal death compared to placebo (18.1% vs 27.5%; RR, 0.66 (95% CI, 0.52-0.83); P = 0.0005; five
studies; 974 women). Meta-analyses of data from four trials (723 women) showed that vaginal progesterone administration was associated with a statistically significant reduction in the risk of preterm birth occurring at < 28
to < 36 gestational weeks (RRs from 0.51 to 0.79), respiratory distress syndrome (RR, 0.47 (95% CI, 0.27-0.81)),
composite neonatal morbidity and mortality (RR, 0.59 (95% CI, 0.38-0.91)), birth weight < 1500g (RR, 0.52 (95%
CI, 0.34-0.81)) and admission to the neonatal intensive care unit (RR, 0.67 (95% CI, 0.50-0.91)). There were no
significant differences in neurodevelopmental outcomes at 2 years of age between the vaginal progesterone and
placebo groups.
Conclusion. This updated systematic review and meta-analysis reaffirms that vaginal progesterone reduces
the risk of preterm birth and neonatal morbidity and mortality in women with a singleton gestation and a mid-trimester CL < 25 mm, without any deleterious effects on neurodevelopmental outcome. Clinicians should continue
to perform universal transvaginal CL screening at 18-24 weeks of gestation in women with a singleton gestation
and to offer vaginal progesterone to those with a CL < 25 mm. Published 2016. This article is a U.S. Government
work and is in the public domain in the USA.
Description:
Perinatology Research Branch, Program for Perinatal Research and Obstetrics, Division of Intramural
Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National
Institutes of Health, Department of Health and Human Services, Bethesda, MD and Detroit, MI, USA, Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA, Department of
Epidemiology and Biostatistics, Michigan State University, East Lansing, MI, USA, Center for Molecular
Medicine and Genetics, Wayne State University, Detroit, MI, USA, Harris Birthright Research Centre
for Fetal Medicine, King’s College Hospital, London, UK, Department of Obstetrics and Gynecology,
University of Kentucky, Lexington, KY, USA, Department of Obstetrics and Gynecology, Zeynep Kamil
Women and Children Diseases Education and Research Hospital, Uskudar, Istanbul, Turkey, Departamento
de Obstetricia e Ginecologia, Hospital do Servidor Publico Estadual ‘Francisco Morato de Oliveira’
and School of Medicine, University of Sao Paulo, Sao Paulo, Brazil, Center for Biomedical Research,
Population Council, New York, NY, USA, Department of Obstetrics and Gynecology, Wayne State University
School of Medicine, Detroit, MI, USA
