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Open Access Study protocol

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

Ushma Mehta1, Christine Clerk2, Elizabeth Allen3, Mackensie Yore4, Esperança Sevene5, Jan Singlovic6, Max Petzold7, Viviana Mangiaterra8, Elizabeth Elefant9, Frank M Sullivan10, Lewis B Holmes11 and Melba Gomes8*

Author Affiliations

1 Independent Pharmacovigilance Consultant, Cape Town, Kenilworth, 7708, South Africa

2 Department of Epidemiology and Disease Control, School of Public Health, University of Ghana, Legon, Ghana, South Africa

3 Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa

4 Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA

5 Department of Pharmacology, Eduardo Mondlane University, Manhiça Foudation, Maputo, Mozambique

6  Data Management Consultant, Libochovany, 41103, Czech Republic

7 Centre for Applies Biostatistics, Department of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

8 World Health Organization, 1211 Avenue Appia, Geneva, 27, Switzerland

9 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

10 Harrington House, 8 Harrington Road, Brighton, BN1 6RE, UK

11 Genetics Unit, Massachusetts General Hospital for Children, 175 Cambridge Street, 504, Boston, MA, 02114, USA

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BMC Pregnancy and Childbirth 2012, 12:89  doi:10.1186/1471-2393-12-89

Published: 3 September 2012

Abstract

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.

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