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

 

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dc.contributor.author Mehta, Ushma en_ZA
dc.contributor.author Clerk, Christine en_ZA
dc.contributor.author Allen, Elizabeth en_ZA
dc.contributor.author Yore, Mackensie en_ZA
dc.contributor.author Sevene, Esperanca en_ZA
dc.contributor.author Singlovic, Jan en_ZA
dc.contributor.author Petzold, Max en_ZA
dc.contributor.author Mangiaterra, Viviana en_ZA
dc.contributor.author Elefant, Elizabeth en_ZA
dc.contributor.author Sullivan, Frank en_ZA
dc.contributor.author Holmes, Lewis en_ZA
dc.contributor.author Gomes, Melba en_ZA
dc.date.accessioned 2015-11-18T04:00:43Z
dc.date.available 2015-11-18T04:00:43Z
dc.date.issued 2012 en_ZA
dc.identifier.citation Mehta, U., Clerk, C., Allen, E., Yore, M., Sevene, E., Singlovic, J., ... & Gomes, M. (2012). Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings. BMC pregnancy and childbirth, 12(1), 89. en_ZA
dc.identifier.uri http://hdl.handle.net/11427/15092
dc.identifier.uri http://dx.doi.org/10.1186/1471-2393-12-89
dc.description.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. en_ZA
dc.language.iso eng en_ZA
dc.publisher BioMed Central Ltd en_ZA
dc.rights This is an Open Access article distributed under the terms of the Creative Commons Attribution License en_ZA
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en_ZA
dc.source BMC Pregnancy and Childbirth en_ZA
dc.source.uri http://www.biomedcentral.com/bmcpregnancychildbirth/ en_ZA
dc.subject.other Pregnancy Registry en_ZA
dc.subject.other Congenital anomaly en_ZA
dc.subject.other Pharmacovigilance en_ZA
dc.subject.other Teratogenicity en_ZA
dc.subject.other Drug exposure en_ZA
dc.subject.other Antiretrovirals en_ZA
dc.subject.other Antimalarials en_ZA
dc.subject.other Birth defects en_ZA
dc.subject.other Neonates en_ZA
dc.subject.other Safety en_ZA
dc.subject.other Resource-limited settings en_ZA
dc.title Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings en_ZA
dc.type Journal Article en_ZA
dc.rights.holder 2012 Mehta et al.; licensee BioMed Central Ltd. en_ZA
uct.type.publication Research en_ZA
uct.type.resource Article en_ZA
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Division of Clinical Pharmacology en_ZA
uct.type.filetype Text
uct.type.filetype Image
dc.identifier.apacitation Mehta, U., Clerk, C., Allen, E., Yore, M., Sevene, E., Singlovic, J., ... Gomes, M. (2012). Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings. <i>BMC Pregnancy and Childbirth</i>, http://hdl.handle.net/11427/15092 en_ZA
dc.identifier.chicagocitation Mehta, Ushma, Christine Clerk, Elizabeth Allen, Mackensie Yore, Esperanca Sevene, Jan Singlovic, Max Petzold, et al "Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings." <i>BMC Pregnancy and Childbirth</i> (2012) http://hdl.handle.net/11427/15092 en_ZA
dc.identifier.vancouvercitation Mehta U, Clerk C, Allen E, Yore M, Sevene E, Singlovic J, et al. Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings. BMC Pregnancy and Childbirth. 2012; http://hdl.handle.net/11427/15092. en_ZA
dc.identifier.ris TY - Journal Article AU - Mehta, Ushma AU - Clerk, Christine AU - Allen, Elizabeth AU - Yore, Mackensie AU - Sevene, Esperanca AU - Singlovic, Jan AU - Petzold, Max AU - Mangiaterra, Viviana AU - Elefant, Elizabeth AU - Sullivan, Frank AU - Holmes, Lewis AU - Gomes, Melba AB - 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. DA - 2012 DB - OpenUCT DO - 10.1186/1471-2393-12-89 DP - University of Cape Town J1 - BMC Pregnancy and Childbirth LK - https://open.uct.ac.za PB - University of Cape Town PY - 2012 T1 - Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings TI - Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings UR - http://hdl.handle.net/11427/15092 ER - en_ZA


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This is an Open Access article distributed under the terms of the Creative Commons Attribution License Except where otherwise noted, this item's license is described as This is an Open Access article distributed under the terms of the Creative Commons Attribution License