Efficacy of daily rectal micronized progesterone for prevention of preterm delivery: a randomized clinical trial

Abstract

Introduction Preterm delivery is the leading cause of neonatal morbidity and mortality and its prevention is always under serious concern. Objective The aim of the present study was to determine the efficacy of rectal progesterone as a maintenance tocolytic after arresting preterm labor, for increasing the duration of pregnancy, and postponing preterm birth. Method The study was performed as a double blind randomized clinical trial on women with preterm labor in whom contractions have been stopped. The eligible women were randomly divided into two groups. In the intervention group (progesterone group), progesterone was administered rectally as a dose of 200 mg daily until 36+6 weeks or spontaneous delivery before that time, whichever came first; and in the placebo group, placebo was administered in a similar manner. Primary outcomes were number of deliveries before 37 weeks of gestation and time to delivery interval in two groups. Secondary outcomes were neonatal Apgar score and weight, and need for NICU admission. Results 160 women finished the study (80 women in each group). The women of the two groups did not have significant difference according to the baseline characteristics. Frequency of preterm labor (earlier than 37 weeks) and mean gestational age at the time of delivery did not show significant difference in two groups. Also, neonatal outcome including Apgar score, birth weight, NICU admission and neonatal complications were not different between the two groups. The pregnancy length was longer in progesterone group (28.84 ± 3.36 VS 21.19 ± 4.62 days), [p = .001, CI 95%: 3.71–4.83]. The time-to-event (delivery) analysis showed a hazard ratio of 1.02 (95% CI 0.36–2.77). Conclusion Rectal progesterone at a daily dose of 200 mg as a maintenance tocolytic agent, cannot lower the frequency of preterm delivery but was suggested to prolong pregnancy length.