Vaginal Progesterone Reduces Preterm Birth, Neonatal Complications in Women With a Short Cervix
PHILADELPHIA -- November 17, 2017 -- Vaginal progesterone reduces preterm birth and neonatal complications in women with a mid-trimester short cervix, according to a meta-analysis published in the American Journal of Obstetrics & Gynecology (AJOG).
A decline in progesterone action is implicated as one of the causes of spontaneous preterm labour and delivery. Physicians worldwide have investigated in many studies whether vaginal progesterone administration to women with a mid-trimester sonographic short cervix reduces the rate of preterm birth; most have been positive.
“The findings of our meta-analysis of individual patient data, which includes all available trials, should reassure clinicians and professional/scientific organisations that vaginal progesterone is efficacious and safe for reducing preterm birth and neonatal morbidity and mortality in women with a sonographic short cervix,” said Roberto Romero, MD, National Institutes of Health (NIH), Bethesda, Maryland.
“In addition, recent evidence assessing the implementation of universal cervical length screening in women with a singleton gestation and treatment with vaginal progesterone to those with a short cervix suggests that this intervention could contribute to a reduction in the rate of preterm birth and associated neonatal morbidity and mortality in the United States,” he said.
The researchers conducted a systematic review and meta-analysis of individual patient data from randomised controlled trials that compared vaginal progesterone with placebo or no treatment in women with a singleton gestation and a midtrimester sonographic cervical length ≤25 mm.
The primary outcome was preterm birth <33 weeks of gestation. Secondary outcomes included adverse perinatal outcomes and neurodevelopmental and health outcomes at age 2 years.
Data were available from 974 women (498 assigned to vaginal progesterone, 476 assigned to placebo) with a cervical length ≤25 mm participating in 5 high-quality trials.
Vaginal progesterone was associated with a significant reduction in the risk of preterm birth <33 weeks of gestation (relative risk [RR], 0.62; 95% confidence interval [CI], 0.47-0.81; P = .0006).
Moreover, 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.
There were 7 (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 = .07).
Maternal adverse events, congenital anomalies, and adverse neurodevelopmental and health outcomes at 2 years of age did not differ between groups.
Reference: DOI: 10.1016/j.ajog.2017.11.576