New global pregnancy register established
Data on outcomes of new drug use in pregnant women are typically very scanty, precisely because such women are explicitly excluded from clinical trials of new medications in order to protect them and their unborn children, says Melba Gomes, from the special programme for Research and Training in Tropical Diseases (TDR).
For major, sometimes life-threatening diseases such as HIV or malaria, pregnant women are often treated with safe, but potentially less efficacious medicines -- until cumulative evidence is gathered on the safety of newer, first-line drugs, often over many years. At the same time, many women in early stages of pregnancy may be exposed to new drugs, usually before their pregnancy is known either to themselves or their health care providers. Better tracking of subsequent pregnancy outcomes in such women, and comparison with their unexposed peers, can help establish safety of new drugs or identify potentially problematic consequences.
"The important thing about this register is that it will collect data on unexposed healthy pregnancies and their outcomes, along with data on pregnant women exposed to drug treatment," says Gomes. "The women not exposed to the drug of interest will act as controls, as it were, in comparison to women exposed to drugs of interest enabling identification of any increased or not increased risk of birth defects due to a drug."
The plans and funding for pilot testing of the Register were approved at an Informal Consultation of the Malaria Pregnancy Register Protocol, 7-8 November 2008 in Geneva, a joint meeting of TDR , the Making Pregnancy Safer Programme of WHO, the HIV Programme, the Quality and Safety of Medicines Programme and the Global Malaria Programme of WHO.
Pilot testing of questionnaires and methods to be used in the Register are being implemented in 2009 in targeted health clinics of at least five African countries, prior to launching to scale. Development of systems for effective tracking of exposures to medicines, and awareness of its importance, is a particular challenge in countries where capacity of antenatal care programmes to conduct such monitoring is currently weak but can be improved.
As part of the effort, WHO/TDR also are issuing calls to researchers worldwide for contributions of results from studies, reports and patient data sets on maternal outcomes and prevalence of birth defects in Asia, Africa and Latin America. These will be included in a planned WHO systematic review of the issue.
For more information please contact:
Dr Melba Gomes
Dr Viviana Mangiaterra