Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth

• Published in: Cochrane database of systematic reviews 2013-07, Vol.2013 (7), p.CD004947
• Main Authors: Dodd, Jodie M, Jones, Leanne, Flenady, Vicki, Cincotta, Robert, Crowther, Caroline A
• Format: Article
• Language: English
• Subjects: 17-alpha-Hydroxyprogesterone - administration & dosage; 17-alpha-Hydroxyprogesterone - adverse effects; Female; Humans; Pregnancy; Pregnancy & childbirth; Pregnancy, High-Risk; Premature Birth - prevention & control; Prenatal Care - methods; Preterm labour; Progesterone - administration & dosage; Progesterone - adverse effects; Randomized Controlled Trials as Topic
• ISSN: 1469-493X
• DOI: 10.1002/14651858.CD004947.pub3

Preterm birth is a major complication of pregnancy associated with perinatal mortality and morbidity. Progesterone for the prevention of preterm labour has been advocated. To assess the benefits and harms of progesterone for the prevention of preterm birth for women considered to be at increased risk of preterm birth and their infants. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (14 January 2013) and reviewed the reference list of all articles. Randomised controlled trials, in which progesterone was given for preventing preterm birth. Two review authors independently evaluated trials for methodological quality and extracted data. Thirty-six randomised controlled trials (8523 women and 12,515 infants) were included. Progesterone versus placebo for women with a past history of spontaneous preterm birth Progesterone was associated with a statistically significant reduction in the risk of perinatal mortality (six studies; 1453 women; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.33 to 0.75), preterm birth less than 34 weeks (five studies; 602 women; average RR 0.31, 95% CI 0.14 to 0.69), infant birthweight less than 2500 g (four studies; 692 infants; RR 0.58, 95% CI 0.42 to 0.79), use of assisted ventilation (three studies; 633 women; RR 0.40, 95% CI 0.18 to 0.90), necrotising enterocolitis (three studies; 1170 women; RR 0.30, 95% CI 0.10 to 0.89), neonatal death (six studies; 1453 women; RR 0.45, 95% CI 0.27 to 0.76), admission to neonatal intensive care unit (three studies; 389 women; RR 0.24, 95% CI 0.14 to 0.40), preterm birth less than 37 weeks (10 studies; 1750 women; average RR 0.55, 95% CI 0.42 to 0.74) and a statistically significant increase in pregnancy prolongation in weeks (one study; 148 women; mean difference (MD) 4.47, 95% CI 2.15 to 6.79). No differential effects in terms of route of administration, time of commencing therapy and dose of progesterone were observed for the majority of outcomes examined. Progesterone versus placebo for women with a short cervix identified on ultrasound Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks (two studies; 438 women; RR 0.64, 95% CI 0.45 to 0.90), preterm birth at less than 28 weeks' gestation (two studies; 1115 women; RR 0.59, 95% CI 0.37 to 0.93) and increased risk of urticaria in women when compared with placebo (one study; 654 women; RR 5.03, 95% CI 1.11 to 22.78). It was not possible to assess