EP11.10: Impact of fetal lung maturation with ambroxol, betamethasone and its combination, its relationship with lamelar body count and neonatal complications

The aim of this study was to compare the effectiveness of the administration of ambroxol vs betamethasone and its combination in high-risk pregnancies and preterm birth. Its relationship with the lamellar bodies count and neonatal complications. 94 high-risk patients between 30 and 35 weeks of gestation were randomly assigned in three groups for fetal lung maturation: group 1 with intravenous ambroxol at dose of 1g per day for 5 consecutive days (n = 28), group 2 with administration of 2 doses of betamethasone (n = 38) and group 3, that included the combination of both (n = 28). The number of lamellar bodies existing in amniotic fluid at the time of birth and neonatal complications were compared between the three groups. The values of the lamellar bodies from group 2 differs significantly (α<0.05) from the 1st and 3rd group. No significant differences are found in lamellar body values (α = 0.743) compared between 1st and 3rd group. Respiratory Distress Syndrome RDS occurred in 68.4% of the betamethasone group, 42.9% of the Ambroxol group and 32.1% of the group treated with both drugs. No difference was found between the ambroxol group and the combination of both drugs. Neonatal hospitalization in the 2nd group was 52.6%, 28.6% in the 1st group and 22.2% in the 3rd group. There is no significant statistical difference between these last groups. The cut-off value of lamellar bodies could be determined at 34,500 and its relationship with the absence of complications e = 0.86 (95% CI 0.75 – 0.98). This therapeutic approach for high-risk patients with threat of imminent preterm birth appears to improve perinatal outcome. Especially in countries with a poor healthcare system and high costs. These results demonstrate that lung maturation with ambroxol achieves a significant improvement in survival rates and achieves less morbidity and hospital stay in the neonatal ICU in premature births. Hence, the combination of both drugs does not produce improvements in the outcome.