Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings

BMC Pregnancy and Childbirth

Study Protocol

Elizabeth Elefant¹  Max Petzold²  Jan Singlovic³  Christine Clerk⁴  Esperança Sevene⁵  Elizabeth Allen⁶  Lewis B Holmes⁷  Frank M Sullivan⁸  Ushma Mehta⁹  Mackensie Yore^1,10  Viviana Mangiaterra^1,11  Melba Gomes^1,11 

[1] Centre de Référence sur les Agents Tératogènes (CRAT), Groupe Hospitalier Universitaire Est, Hôpital Armand Trousseau, 26, av du Dr Netter, 75571, Paris, cedex, 12, France;Centre for Applies Biostatistics, Department of Medicine,, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;Data Management Consultant, 41103, Libochovany, Czech Republic;Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Legon, Ghana, South Africa;Department of Pharmacology, Eduardo Mondlane University, Manhiça Foudation, Maputo, Mozambique;Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa;Genetics Unit, Massachusetts General Hospital for Children, 175 Cambridge Street, 504, 02114, Boston, MA, USA;Harrington House, 8 Harrington Road, BN1 6RE, Brighton, UK;Independent Pharmacovigilance Consultant, 7708, Cape Town, Kenilworth, South Africa;Stanford University School of Medicine, 291 Campus Drive, 94305, Stanford, CA, USA;World Health Organization, 1211 Avenue Appia, Geneva, 27, Switzerland;

关键词: Pregnancy Registry;    Congenital anomaly;    Pharmacovigilance;    Teratogenicity;    Drug exposure;    Antiretrovirals;    Antimalarials;    Birth defects;    Neonates;    Safety;    Resource-limited settings;   

DOI  :  10.1186/1471-2393-12-89

 received in 2012-08-02, accepted in 2012-08-24,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundThe 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/DesignSentinel 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.DiscussionIn 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 improve maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy.

【 授权许可】

Unknown   
© Mehta et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.