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

BMC Pregnancy and Childbirth

Melba Gomes¹  Lewis B Holmes^1,10  Frank M Sullivan^1,11  Elizabeth Elefant⁹  Viviana Mangiaterra¹  Max Petzold⁵  Jan Singlovic³  Esperança Sevene²  Mackensie Yore⁴  Elizabeth Allen⁷  Christine Clerk⁸  Ushma Mehta⁶ 

[1] World Health Organization, 1211 Avenue Appia, Geneva, 27, Switzerland;Department of Pharmacology, Eduardo Mondlane University, Manhiça Foudation, Maputo, Mozambique; Data Management Consultant, Libochovany, 41103, Czech Republic;Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA;Centre for Applies Biostatistics, Department of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;Independent Pharmacovigilance Consultant, Cape Town, Kenilworth, 7708, South Africa;Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa;Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Legon, Ghana, South Africa;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;Genetics Unit, Massachusetts General Hospital for Children, 175 Cambridge Street, 504, Boston, MA, 02114, USA;Harrington House, 8 Harrington Road, Brighton, BN1 6RE, UK

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

Others  :  1152441
DOI  :  10.1186/1471-2393-12-89

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

【 摘 要 】

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

【 授权许可】

   
2012 Mehta et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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