What is it about?
There is a lack of scientific research evidence for the routine use of ambroxol for women at risk of preterm birth for preventing neonatal respiratory distress syndrome (RDS). RDS is a disease caused by a deficiency of surfactants (substances that lower surface tension) in the lungs of newborn babies. These substances keep the alveoli at the ends of the airways open and enable the entry of air into the lungs so that the newborn is able to breathe and oxygenate its body. RDS occurs mainly in preterm newborns. A number of interventions such as giving the baby surfactant and prenatal corticosteroids are used to prevent the syndrome. Ambroxol facilitates the removal of bronchial secretions and can stimulate production of surfactant. Giving ambroxol to pregnant women during preterm labour may be protective for the newborn babies, with fewer maternal adverse effects with prenatal steroids. The main side-effects of ambroxol are diarrhoea, gastric irritation, nausea, vomiting and headache
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Why is it important?
Most studies have been conducted in newborns, however, there is insufficient information to determine whether giving ambroxol to pregnant women at risk of pretermbirth prevents neonatal RDS in their infants. The purpose of this review is to evaluate the efficacy of administering ambroxol to mothers during preterm labour to reduce the incidence of RDS and subsequently to reduce neonatal morbidity and mortality.
Perspectives
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
Dr Alejandro G Gonzalez Garay
National Institute of Pediatrics
Read the Original
This page is a summary of: Ambroxol for women at risk of preterm birth for preventing neonatal respiratory distress syndrome, Cochrane Database of Systematic Reviews, October 2014, Wiley,
DOI: 10.1002/14651858.cd009708.pub2.
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