title: Vaginal progesterone to prevent preterm birth in pregnant women with a sonographic short cervix: clinical and public health implications.
abstract: Vaginal progesterone administration to women with a sonographic short cervix is an efficacious and safe intervention used to prevent preterm birth and neonatal morbidity and mortality. The clinical and public health implications of this approach in the United States have been critically appraised and compared to other therapeutic interventions in obstetrics. Vaginal progesterone administration to women with a transvaginal sonographic cervical length (CL) ≤25 mm before 25 weeks of gestation is associated with a significant and substantial reduction of the risk for preterm birth from <28 to <35 weeks of gestation, respiratory distress syndrome, composite neonatal morbidity and mortality, admission to the neonatal intensive care unit, and mechanical ventilation. These beneficial effects have been achieved in women with a singleton gestation, with or without a history of spontaneous preterm birth, and did not differ significantly as a function of CL (<10 mm, 10-20 mm, or 21-25 mm). The number of patients required for treatment to prevent 1 case of preterm birth or adverse neonatal outcomes ranges from 10-19 women. The number needed to screen for the prevention of 1 case of preterm birth before 34 weeks of gestation is 125 women, and 225 for the prevention of 1 case of major neonatal morbidity or neonatal mortality. Several cost-effectiveness and decision analyses have shown that the combination of universal transvaginal CL screening and vaginal progesterone administration to women with a short cervix is a cost-effective intervention that prevents preterm birth and associated perinatal morbidity and mortality. Universal assessment of CL and treatment with vaginal progesterone for singleton gestations in the United States would result in an annual reduction of approximately 30,000 preterm births before 34 weeks of gestation and of 17,500 cases of major neonatal morbidity or neonatal mortality. In summary, there is compelling evidence to recommend 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, regardless of the history of spontaneous preterm birth, with the goal of preventing preterm birth and neonatal morbidity and mortality.
authors.affiliation: Perinatology Research Branch, 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.
authors.forename: Agustin
authors.initials: A
authors.lastname: Conde-Agudelo
authors.affiliation: Perinatology Research Branch, 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; Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI; Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI; Center for Molecular Medicine and Genetics, Wayne State University, Detroit, MI. Electronic address: romeror@mail.nih.gov.
authors.forename: Roberto
authors.initials: R
authors.lastname: Romero
mesh_terms: D000282:Administration, Intravaginal; D054791:Cervical Length Measurement; D002584:Cervix Uteri / Q000000981:diagnostic imaging*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data; D011247:Pregnancy; D059285:Pregnancy, Twin; D047928:Premature Birth / Q000517:prevention & control*; D011374:Progesterone / Q000627:therapeutic use*; D011372:Progestins / Q000627:therapeutic use*; D011634:Public Health; D012121:Respiration, Artificial / Q000706:statistics & numerical data; D012127:Respiratory Distress Syndrome, Newborn / Q000453:epidemiology; D016896:Treatment Outcome
chemical_list: D011372:Progestins; D011374:Progesterone
keywords: biomarker; cervical length; cost-effectiveness; neonatal morbidity; pregnancy; prematurity; prevention; screening; singleton gestation; twin gestation; ultrasound