title: Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Independent Pharmacovigilance Consultant, Cape Town, Kenilworth 7708, South Africa.
authors.forename: Ushma
authors.initials: U
authors.lastname: Mehta
authors.forename: Christine
authors.initials: C
authors.lastname: Clerk
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Allen
authors.forename: Mackensie
authors.initials: M
authors.lastname: Yore
authors.forename: Esperança
authors.initials: E
authors.lastname: Sevene
authors.forename: Jan
authors.initials: J
authors.lastname: Singlovic
authors.forename: Max
authors.initials: M
authors.lastname: Petzold
authors.forename: Viviana
authors.initials: V
authors.lastname: Mangiaterra
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Elefant
authors.forename: Frank M
authors.initials: FM
authors.lastname: Sullivan
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Holmes
authors.forename: Melba
authors.initials: M
authors.lastname: Gomes
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D016208:Databases, Factual; D005260:Female; D006801:Humans; D008427:Maternal Health Services; D060735:Pharmacovigilance; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care; D012042:Registries / Q000592:standards; D014944:World Health Organization