Comparison of Risk of Preterm Labor between Vaginal Progesterone and17-Alpha-Hydroxy-Progesterone Caproate in Women with Threatened Abortion: A Randomized Clinical Trial.

BACKGROUND

Threatened miscarriage is a common complication in pregnancy that leads to adverse pregnancy outcomes such as preterm labor. This study aimed to compare the vaginal progesterone (Cyclogest) versus 17-alpha-hydroxyprogesterone caproate (Proluton) on preventing preterm labor in pregnant women with threatened abortion at less than 34 weeks' gestational age.

MATERIALS AND METHODS

This balanced randomized, double-blind, single-center controlled clinical trial included 190 women with threatened abortion. They were then randomly allocated into Cyclogest (n=95) and 17-alpha-hydroxyprogesterone caproate (Proluton, n=95) groups. Interested outcome was preterm labor less than 34 weeks. The Pearson chi-square and Student's t test were used to compare two groups. The data were analyzed by Stata software version 13.

RESULTS

The risks of preterm labor less than 34 weeks in Proluton and Cyclogest groups were 8.6 and 6.52%, respectively. There was no significant difference for risk of preterm labor less than 34 weeks [relative ratio (RR): 1.31, 95% confidence interval (CI): 0.47- 3.66, P=0.59] between two groups.

CONCLUSION

Risk of preterm labor in the vaginal progesterone group and 17-alpha-hydroxyprogesterone caproate group in pregnant women with threatened abortion is the same (

REGISTRATION NUMBER

IRCT2014123120504N1).