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

Additional files

Additional file 1:

Case Record Form 1. Antenatal data sheet. Data capture form used at initial recruitment and during antenatal follow-up visits.

Format: PDF Size: 633KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data

Additional file 2:

Case Record Form 2. Pregnancy Outcome Sheet Data capture form used during labor/delivery period or during assessment of mother and infant within 12 weeks after birth.

Format: PDF Size: 86KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data

Additional file 3:

Case Record Form 3. Data capture form used during the confirmatory assessment of the infant for the suspected birth defect. To be completed by a relevant medical specialist (e.g. neonatologist, teratologist).

Format: PDF Size: 54KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data

Additional file 4:

Guidance on the use of medicines during pregnancy. A note given to recruited women on the prudent use of medicines during the course of the pregnancy.

Format: PDF Size: 41KB Download file

This file can be viewed with: Adobe Acrobat Reader

Open Data