Effect of nifedipine with and without sildenafil citrate for the management of preterm labor in pregnant women: A randomized clinical trial

Background: Preterm labor is one of the main causes of neonatal mortality and its treatment is still challenging. Objective: The study aimed to compare the effectiveness of nifedipine (Nif) with and without sildenafil citrate (SC) for the treatment of preterm labor in pregnant women. Materials and Methods: In this clinical trial study, ۱۲۶ pregnant women referred to the Fatemieh hospital, Hamadan, Iran with a complaint of preterm labor were evaluated. Participants were randomly divided into ۲ groups of Nif ۲۰ mg orally (single dose), then ۱۰ mg every ۶-hr, and at the same time vaginal SC ۲۵ mg every ۸ hr (Nif + SC) or Nif alone. Treatment was continued for ۴۸-۷۲ hr if uterine contractions did not resolve in both groups. Delivery rates at the time of hospitalization and neonatal outcome were compared between the ۲ groups. Results: No statistically significant difference was observed between the ۲ study groups in terms of mean age, gestational age, body mass index, and parity. ۷۶.۲% of Nif + SC participants in the first ۷۲ hr of hospitalization and ۵۷.۲% of Nif participants remained without delivery (p = ۰.۰۲). The neonatal hospitalization rate of the Nif + SC group in the neonatal intensive care unit was ۲۵.۴% and in the Nif group was ۴۲.۹% (p = ۰.۰۳). Conclusion: Nif with SC is superior to Nif alone in women at risk of preterm labor due to increasing gestational age and better neonatal outcomes.

کلیدواژه ها:

Nifedipine ، preterm labor ، Sildenafil citrate ، Randomized trial. ، نیفیدپین ، زایمان ، سلیدانافیل سیترات ، کارآزمایی بالینی.