New pregnancy registry protocol published

TDR news item
13 December 2012

A new protocol has been published in BMC Pregnancy and Childbirth for collecting data on the risks of birth defects due to medicines for diseases like HIV and malaria. The major components of first line treatments for these diseases are not recommended during the first trimester, yet many women may take these medications before they are aware that they are pregnant. In sub-Saharan Africa, 68% of the world’s HIV population reside and approximately 25 million pregnant women are at risk of malaria, so the risks are great.

The protocol is neither disease nor drug-specific. Indeed, the power of the approach lies in its broad application to a variety of settings in which women may have more than one infectious disease or condition during the course of the pregnancy and may also have been exposed to many drugs. Its methods, case record forms and training materials (including a DVD showing how to conduct a surface examination of a newborn) have been tested for feasibility in five countries (four in Africa and one in South America), further refined and used in the WHO Pregnancy Registry. The approach is integrated within the reproductive health system of the country, specifically antenatal clinics and labor/delivery facilities.

There are three important features of this pregnancy registry protocol which stand out from most other registries. The first is the simplicity of including women agreeing to take part at their first facility visit for care during the pregnancy. This not only represents the population of pregnant women coming for care but also enables later comparison of birth defects among women who have been exposed to a medicine with those who have not. The second feature is the generic applicability of the approach irrespective of drug or disease, and the third is the improvement of staff capacity to manage and monitor pregnancies and newborns. These qualities add to the practicality and cost-effectiveness of the protocol.

The materials developed are available to any country wishing to join the registry, on condition that there is a commitment to train the staff to use these materials to obtain reliable data on drug exposure and to conduct a systematic surface examination of the newborn. The registry builds capacity within the health system to improve maternal and neonatal care as well as to serve as a sentinel surveillance system for the safety of medicines used in pregnant women.

The specific objectives of the WHO Pregnancy Registry are to:

  • Build capacity to obtain reliable information on obstetric, medical, and drug history during pregnancy and diagnose, assess, monitor and manage pregnancy and the outcomes of pregnancy including congenital malformations, stillbirths and prematurity.
  • Quantify the baseline risk of major congenital malformations in the absence of drug exposure during the course of pregnancy.
  • Quantify the risk of major congenital malformations associated with exposure to medicines during the course of pregnancy.
  • Identify other obstetric, therapeutic and clinical factors that may contribute to the risk of major congenital anomalies and other adverse birth outcomes in pregnant women.
  • Support a culture of drug safety awareness among women and their providers in participating countries and avoid preventable adverse drug-related pregnancy outcomes.
  • Develop an ongoing surveillance system of maternal and newborn health that strengthens the health system to improve maternal and neonatal outcomes.

For more information, please contact:

Melba Gomes