Efficacy of 17alpha- hydroxy progesterone on decreasing preterm labor in ART pregnancies: a randomized clinical trial

ABSTRACT

Preterm labor [PTL] is one of the most important causes in neonatal mortality and morbidity. Late preterm labor [34-36w] includes 75% of such birth. Assisted reproductive technology [ART] pregnant women are at increased risk of PTL. The study has been undertaken to determine whether beginning and continuing 17-alpha hydroxy progesterone caproate can reduce risk of PTL or change neonatal mortality. In a double-blind clinical randomized control trial, 106 women were treated by ART technique for their infertility and in gestational age at 16 weeks entered in our study. In one group, 17-alpha hydroxy progesterone caproate [Femolife] was injected intramuscularly every week until 36 weeks of gestation and in another group; placebo was injected from 16 until 36 weeks of gestetion. Data collected from pregnancy outcomes, infancy, and subsidiary problems were statistically analyzed by a questionnaire. The risk of PTL in placebo group was 2.48 higher than control group that was not significant [Cl 0.81-9.94]. Femolife side effect in case group was gestational diabetes and local complication was not frequent. NICU admission was not significantly different between groups. Although it seems that 17-alpha hydroxy progesterone caproate does not cause significantly decrease in PTL in singleton ART gestations but any reduction of PTL in such high risk pregnancies may improve final gestational outcome. There is critical need for larger clinical trials to better understanding causes of PTL, specifically late preterm labor, to prevent mortality and morbidity in ART gestation