Study protocol

BMC Pregnancy and Childbirth

, 12:89

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

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

  • Ushma MehtaAffiliated withIndependent Pharmacovigilance Consultant
  • , Christine ClerkAffiliated withDepartment of Epidemiology and Disease Control, School of Public Health, University of Ghana
  • , Elizabeth AllenAffiliated withDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town
  • , Mackensie YoreAffiliated withStanford University School of Medicine
  • , Esperança SeveneAffiliated withDepartment of Pharmacology, Eduardo Mondlane University, Manhiça Foudation
  • , Jan SinglovicAffiliated with Data Management Consultant
  • , Max PetzoldAffiliated withCentre for Applies Biostatistics, Department of Medicine, Sahlgrenska Academy, University of Gothenburg
  • , Viviana MangiaterraAffiliated withWorld Health Organization
  • , Elizabeth ElefantAffiliated withCentre de Référence sur les Agents Tératogènes (CRAT), Groupe Hospitalier Universitaire Est, Hôpital Armand Trousseau
    • , Frank M SullivanAffiliated withHarrington House
    • , Lewis B HolmesAffiliated withGenetics Unit, Massachusetts General Hospital for Children
    • , Melba GomesAffiliated withWorld Health Organization Email author 



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.


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.


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.


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