The evaluation of the effect of cyclogest in comparison with placebo in threatened preterm labour at 24-32 weeks of gestation

Background: The efficacy of maintenance tocolytic therapy after successful arrest of preterm labour remains controversial. The purpose of this study was to evaluate the efficacy of 400 mg of daily vaginal progesterone (cyclogest) after successful parenteral tocolysis to and Methods: In this randomised, double-blind, placebo-controlled trial, 85 participants were randomly allocated to either 400 mg daily of vaginal progesterone or placebo until 34 weeks of gestation. The primary outcomes were the time until delivery (latency period) and cervical length after one week of treatment. Secondary outcome were GA on delivery, type of delivery, incidence of low birth weight, perinatal morbidity and mortality.Results: Longer mean latency until delivery (53.6±16.8 vs 34.5±12.9) days P=0.0001; longer mean of gestational age on delivery (37.5±2.2 vs 34.2±2.1) weeks P=0.0001; cervical length after one week of treatment (27.5±5.5 vs 20.7±3.1) mm P=0.0001; low birth weight 12 (29.3%) vs 19 (57.6%) P = 0.01; and NICU admission 9 (22%) vs 15 (45.5%), were significantly different between the two groups. No significant differences were found between neonatal death 1 (2.4%) vs 2 (6.1%), P = 0.43; RDS 5 (12.2%) vs 8 (24.2%), P = 0.17; and need to mechanical ventilator 2 (5.4%) vs 6 (18.2%) P = 0.136, for the progesterone and placebo groups, respectively.Conclusion: Daily administration of 400 mg vaginal progesterone after successful parenteral tocolysis increases latency preceding delivery and improves cervical shortening and neonatal outcome in women with preterm labour.

Keywords:

Preterm labour , Tocolytic therapy , Vaginal progesterone , Neonatal morbidity , Neonatal mortality.