Cervical Assessment With Progesterone in the Prevention of Preterm Birth: A Strategy Based On Cost-Effectiveness

Nicolaides

Ultrasound Obstet Gynecol

et al. 2016

216

159

ObjectiveTo 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.MethodsThis 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.ResultsFive 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 < 1500 g (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.ConclusionThis 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.

Section: Discussionmentioning

confidence: 99%

Vaginal progesterone decreases preterm birth ≤ 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta‐analysis including data from the OPPTIMUM study

Nicolaides

Ultrasound Obstet Gynecol

et al. 2016

216

159

“…135–144 Moreover, emerging evidence from recent studies conducted in hospitals located in the United States 144–146 and 1 Australian state 147 suggests that the implementation of universal cervical length screening and vaginal progesterone administration to patients with a sonographic short cervix is associated with a significant reduction in the rates of preterm birth. Several of these studies included women with a previous spontaneous preterm birth.…”

Section: Commentmentioning

confidence: 99%

Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis

American Journal of Obstetrics and Gynecology

Fonseca

et al. 2018

127

“…Currently, there is strong evidence indicating that universal transvaginal sonographic CL screening and vaginal progesterone administration for women with a short cervix is a cost-effective intervention to prevent preterm birth and associated morbidity and mortality, regardless of the cutoff used to define a short cervix in the decision and economic analyses (≤15 mm, 57–59 ≤20 mm, 60 ≤25 mm, 57,61,62 10–20 mm, 63 or 10–30 mm 64 ). Moreover, the analysis of Combs 65 provided compelling evidence that this strategy satisfies the 10 criteria that the World Health Organization considers to be a good screening test.…”

Section: Introductionmentioning

confidence: 99%

Vaginal progesterone to prevent preterm birth in pregnant women with a sonographic short cervix: clinical and public health implications

American Journal of Obstetrics and Gynecology

2016

Vaginal progesterone administration to women with a sonographic short cervix is 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 of 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 one case of preterm birth or adverse neonatal outcomes ranges from 10 to 19 women. The number needed to screen for the prevention of one case of preterm birth before 34 weeks of gestation is 125 women, and 225 for the prevention of one 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.