Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data

• R. Romero
• K. Nicolaides
• A. Conde-Agudelo
• A. Tabor
• J.M. O'Brien
• E. Cetingoz
• E. Da Fonseca
• G. Creasy
• K. Klein
• L. Rode
• P. Soma-Pillay
• S. Fusey
• C. Cam
• Z. Alfi revic
• S.S. Hassan

Abstract

Objective: To determine whether the use of vaginal progesterone in asymptomatic women with a sonographic short cervix (<25 mm) in the midtrimester reduces the risk of preterm birth and improves neonatal morbidity and mortality.

Study Design: Individual patient data metaanalysis of randomized controlled trials.

Results: Five trials of high quality were included with a total of 775 women and 827 infants. Treatment with vaginal progesterone was associated with a significant reduction in the rate of preterm birth <33 weeks (relative risk [RR], 0,58; 95% confidence interval [CI], 0,42–0,80), <35 weeks (RR, 0,69; 95% CI, 0,55–0,88), and <28 weeks (RR, 0,50; 95% CI, 0,30–0,81); respiratory distress syndrome (RR, 0,48; 95% CI, 0,30–0,76); composite neonatal morbidity and mortality (RR, 0,57; 95% CI, 0,40–0,81); birthweight <1500 g (RR, 0,55; 95% CI, 0,38–0,80); admission to neonatal intensive care unit (RR, 0,75; 95% CI, 0,59–0,94); and requirement for mechanical ventilation (RR, 0,66; 95% CI, 0,44–0,98). There were no significant differences between the vaginal progesterone and placebo groups in the rate of adverse maternal events or congenital anomalies.

Conclusion: Vaginal progesterone administration to asymptomatic women with a sonographic short cervix reduces the risk of preterm birth and neonatal morbidity and mortality.