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. (19th July 2016)

• Record Type: Journal Article
• Authors: Romero, R.; Nicolaides, K. H.; Conde‐Agudelo, A.; O'Brien, J. M.; Cetingoz, E.; Da Fonseca, E.; Creasy, G. W.; Hassan, S. S.
• Is Part Of: Ultrasound in obstetrics & gynecology. Volume 48:Number 3(2016)
• Page Start: 308
• Page End: 317
• Publication Date: 2016-07-19
• Subjects: cervical length -- neonatal morbidity -- neonatal mortality -- prematurity -- preterm delivery -- progestins -- progestogens -- transvaginal ultrasound; Ultrasonics in obstetrics -- Periodicals; Generative organs, Female -- Diseases -- Diagnosis -- Periodicals; Diagnosis, Ultrasonic -- Periodicals; Genital Diseases, Female -- ultrasonography -- Periodicals; Ultrasonography, Prenatal -- Periodicals; 618.047543
• DOI: 10.1002/uog.15953
• Languages: English
• ISSNs: 0960-7692

Abstract

Abstract: Objective: To 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. Methods: This 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. Results: Five 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. Conclusion: This 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. Abstract : This article has been selected for Journal Club. Clickhere to view slides and discussion points.