Does Vaginal Progesterone Improve Birth Outcomes for Mothers with Short Cervix?
BACKGROUND AND PURPOSE:
Efficacy of vaginal progesterone to prevent preterm birth and adverse perinatal outcomes in women with short cervix has been questioned in recent literature
Romero et al. (AJOG, 2018) examined whether vaginal progesterone prevents preterm birth and improves perinatal outcomes in asymptomatic women with a singleton gestation and a short cervix ≤25mm
Systematic Review and meta-analysis
Literature search of eligible randomized controlled trials (RCTs) comparing vaginal progesterone with placebo/no treatment in women with a singleton gestation and a midtrimester sonographic cervical length ≤25 mm
Primary outcome: Preterm birth <33 weeks of gestation
Secondary outcomes: Preterm birth <37, <36, <35,
<34, <32, <30 and <28 weeks of gestation and other adverse perinatal outcomes and neurodevelopmental and health outcomes at 2 years of age
Data was pooled from 974 women with a cervical length ≤25 mm participating in five high-quality trials
Vaginal progesterone was linked to a significantly reduced risk of preterm birth <33 weeks of gestation (relative risk [RR] 0.62, 95% CI 0.47-0.81, P=0.0006; high-quality evidence)
Vaginal progesterone significantly decreased the risk of preterm birth <36, <35, <34, <32, <30 and <28 weeks of gestation, spontaneous preterm birth <33 and <34 weeks of gestation, respiratory distress syndrome, composite neonatal morbidity and mortality, birthweight <1500 and <2500 g, and admission to the neonatal intensive care unit (RRs from 0.47 to 0.82; high-quality evidence for all)
There were seven (1.4%) neonatal deaths in the vaginal progesterone group and 15 (3.2%) in the placebo group (RR 0.44, 95% CI 0.18-1.07, P=0.07; low-quality evidence)
Maternal adverse events, congenital anomalies, and adverse neurodevelopmental and health outcomes at 2 years of age did not differ between groups
Vaginal progesterone is safe, can decrease preterm birth risk and improve perinatal outcomes in women with short cervix regardless of previous history of preterm birth
Vaginal progesterone, in this study, was associated with a 41% reduction in the frequency of a composite outcome of neonatal death combined with common neonatal complications seen in preterm newborns
The authors calculate that a universal transvaginal cervical length screening program and treatment with vaginal progesterone for those with a cervical length ≤25 mm would prevent 31,800 preterm births <34 weeks of gestation and 19,800 cases of major neonatal morbidity or mortality
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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