Low-dose prednisone and pregnancy prolongation in threatened preterm birth a randomized pilot study

Abstract Objectives To compare pregnancy prolongation and neonatal outcomes in women with signs of threatened preterm birth (PTB) and intact membranes by administration of low-doses of prednisone for 3 weeks compared to women who received standard protocols of tocolysis and respiratory distress syndrome (RDS) prophylaxis in a pilot randomized controlled trial. Methods We randomized 26 women with signs of threatened PTB and intact membranes between 24 and 34 weeks of gestation to either continued prednisone administration for 3 weeks following the initiation of the standard protocol (intervention group) or standard therapy for threatened PTB (control group). The primary outcome was the gestational length in women with and without using low-doses of prednisone. The secondary outcome included incidence of RDS, intraventricular hemorrhage, necrotizing enterocolitis, the need for mechanical ventilation, and perinatal mortality in newborns from both study groups. Results Participants in the intervention group had significantly longer pregnancy prolongation than the control group (65.38 vs. 40.54 days, p=0.001). Although the difference was not statistically significant (p=0.153), the gestational age at delivery in the intervention group (38.35 weeks) was 10 days longer than in the control group (36.89 weeks). There were no significant differences between the groups in neonatal outcomes. Conclusions The first pilot randomized controlled study on low-dose prednisone in threatened PTB and intact membranes suggests it may prolong pregnancy without adverse neonatal outcomes. Due to the small sample size and single-centre design, these preliminary findings should be interpreted with caution and confirmed in larger, adequately powered trials.