Ambroxol for women at risk of preterm birth for preventing neonatal respiratory distress syndrome

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We did not identify any trials comparing ambroxol with dexamethasone (corticosteroid) in this review. Nor did we identify any trials comparing ambroxol combined with corticosteroid versus corticosteroid alone, or placebo/no treatment. The review identified 14 small studies involving a total of 1047 women (and their 1077 newborns), that compared ambroxol with corticosteroid (betamethasone), or to placebo/no treatment. Three of the studies did not report on the outcomes of interest for this review. The results of the review are based on very low to moderate quality evidence. There were no clear evidence of differences in the incidence of RDS or perinatal mortality in newborns of women who were given ambroxol when compared with newborns of women who received either a corticosteroid (betamethasone) or placebo/no treatment. Similarly, there was no clear difference between groups in terms of nausea and vomiting (the only maternal adverse effects that were reported). For the review’s secondary outcomes, none of the included studies reported on the incidence of bronchopulmonary dysplasia, periventricular haemorrhage, necrotising enterocolitis or rate of maternal mortality. One small study (comparing ambroxol with placebo/no treatment) found no difference between groups for the neonatal outcomes of ’need for mechanical ventilation’ or ’administration of pulmonary surfactant’. There is insufficient evidence to support or refute the practice of giving ambroxol to pregnant women at risk of preterm birth for preventing neonatal RDS. More research in this area is necessary in order to evaluate the effectiveness and safety of this intervention

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