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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings
BMC Pregnancy and Childbirth, Volume 12, Article 89, Year 2012
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Description
Background: The absence of robust evidence of safety of medicines in pregnancy, particularly those for major diseases provided by public health programmes in developing countries, has resulted in cautious recommendations on their use. We describe a protocol for a Pregnancy Registry adapted to resource-limited settings aimed at providing evidence on the safety of medicines in pregnancy.Methods/Design: Sentinel health facilities are chosen where women come for prenatal care and are likely to come for delivery. Staff capacity is improved to provide better care during the pregnancy, to identify visible birth defects at delivery and refer infants with major anomalies for surgical or clinical evaluation and treatment. Consenting women are enrolled at their first antenatal visit and careful medical, obstetric and drug-exposure histories taken; medical record linkage is encouraged. Enrolled women are followed up prospectively and their histories are updated at each subsequent visit. The enrolled woman is encouraged to deliver at the facility, where she and her baby can be assessed.Discussion: In addition to data pooling into a common WHO database, the WHO Pregnancy Registry has three important features: First is the inclusion of pregnant women coming for antenatal care, enabling comparison of birth outcomes of women who have been exposed to a medicine with those who have not. Second is its applicability to resource-poor settings regardless of drug or disease. Third is improvement of reproductive health care during pregnancies and at delivery. Facility delivery enables better health outcomes, timely evaluation and management of the newborn, and the collection of reliable clinical data. The Registry aims to improves maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy. © 2012 Mehta et al.; licensee BioMed Central Ltd.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3500715/bin/1471-2393-12-89-S1.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3500715/bin/1471-2393-12-89-S2.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3500715/bin/1471-2393-12-89-S3.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3500715/bin/1471-2393-12-89-S4.pdf
Authors & Co-Authors
Mehta, Ushma C.
South Africa, Cape Town
Independent Pharmacovigilance Consultant
Clerk, Christine Alexandra
Ghana, Accra
University of Ghana
Allen, Elizabeth N.
South Africa, Cape Town
University of Cape Town
Yore, Mackensie A.
United States, Stanford
Stanford University School of Medicine
Sevene, Esperança Jp
Mozambique, Maputo
Universidade Eduardo Mondlane
Singlovic, Jan
Czech Republic
Data Management Consultant
Petzold, Max Gustav
Sweden, Gothenburg
Sahlgrenska Akademin
Mangiaterra, Viviana
Switzerland, Geneva
Organisation Mondiale de la Santé
Elefant-Amoura, Elisabeth
France, Paris
Hôpital Armand-trousseau
Sullivan, Frank M.
United Kingdom, Brighton
Harrington House
Holmes, Lewis Ball
United States, Boston
Massachusetts General Hospital
Gomes, Melba F.
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 27
Authors: 12
Affiliations: 11
Identifiers
Doi:
10.1186/1471-2393-12-89
e-ISSN:
14712393
Research Areas
Health System And Policy
Maternal And Child Health
Sexual And Reproductive Health
Participants Gender
Female