[Ambroxol in comparison with betamethasone for the stimulation of antepartal lung maturity. A clinical double-blind study].

Stimulation of the surfactant production in fetal cells by ambroxol (metabolite VIII of bromhexine) has been investigated in human and animal experiments. There are no contraindications for the prenatal use of ambroxol, which is also well tolerated in high dose. Therefore the 1st Department of Obstetrics and Gynecology in Vienna took part in a multicentric clinical trial, where the allocation between cortisone and ambroxol was randomised in a double blind fashion. The 1st Department included 34 women between 30 and 36 weeks of pregnancy with premature labour or indicated premature induction. Amniotic fluid samples were taken by amniocentesis before therapy to prove lung immaturity by measurement of the L/S ratio and the dynamic surface tension. Following doses were used for this clinical trial group A: 1,000 mg ambroxol in 500 ml 5% glucose infusion i.v. daily from day 1 to day 5 and 2 ml placebo-injection i.m. on day 1 and day 2, group B: 8 mg Betamethasone i.m. on day 1 and day 2 and 500 ml 5% glucose infusion with a placebo daily from day 1 to day 5. The patients were treated at least 3 days; in all cases amniotic fluid samples were taken after therapy, to examine the L/S ratio and the dynamic surface tension. 29 women of the 34 fulfilled the above criteria, 15 in group A and 14 in group B (1 twin pregnancy). With the pretreatment parameters of lung maturity being similar in both groups ambroxol was found to lead to a marked but not significant improvement of the L/S ratio and the surface tension.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes