(Vienna, 10 Dec. 2010) A recently published international multi-centre study under the auspices of MedUni Vienna which examined the effects of drug substitution treatment on mother and child during pregnancy can be considered a pioneering work. At the same time the work represents a model for drug trials on pregnant women and has appeared in the renowned “New England Journal of Medicine”.
Methadone is the standard treatment for opiate dependency during pregnancy. Administration of this agent before the birth is associated with “neonatal abstinence syndrome” (NAS) in newborn babies, however, which is manifested in an overstrained central nervous system and dysfunctions of the autonomic nervous system and requires further medication and longer hospital stays.
In a randomised double blind trial Ao. Univ. Prof. Dr. Gabriele Fischer, addiction researcher at the Department of Psychiatry and Psychotherapy, has now joined together with colleagues from the USA to examine the effect of the alternative agent “buprenorphine”, which is used in opiate dependency but was not sufficiently investigated in pregnant women.
The results show safety in women and children for both drugs, but with methadone therapy a higher number of patients remained in treatment. Both remedies show a comparable clear reduction in the consumption of legal/illegal addictive drugs. All newborn babies were healthy with comparable parameters to children exposed to no medication in the uterus (time of birth, weight, APGAR etc.). The immediate neonatal development shows a significantly more positive result for buprenorphine, however. As well as psychopharmacological therapy, all women were also given behavioural therapy interventions.
Requirements for successfully carrying out this very extensive international study were ethical approval and also the presence of a professional interdisciplinary research and therapy structure, as can be found at MedUni Vienna. The Vienna team of Gabriele Fischer together with the Department of Obstetrics and Gynaecology, the Department of Paediatrics and Adolescent Medicine and the Division of Medical and Chemical Laboratory Diagnostics were also able to contribute the largest part of the data.
The addicted pregnant women had to come to the clinic every day for eight months to be checked and to take the medication, the newborn babies were closely evaluated as in-patients on a standardised basis over ten days following the birth to check their neuromotor development. A basic prerequisite is also adequate research promotion, for which 48 million dollars has been provided by the US National Institute of Health (NIH), including with the target of establishing a “role model” for medication research in pregnant women. In this regard the study can be considered a pioneering work.
Gabriele Fischer explains: “Women overall, and pregnant women in particular, are still at a clear disadvantage in terms of examinations for the effect of medication because they are usually excluded from scientific studies, and the effects of medication on children can often not be seen until during the course of their development.“
Possible therapy for drug-addicted pregnant women
A recently published international multi-centre study under the auspices of MedUni Vienna which examined the effects of drug substitution treatment on mother and child during pregnancy can be considered a pioneering work. At the same time the work represents a model for drug trials on pregnant women and has appeared in the renowned “New England Journal of Medicine”.