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

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dc.contributor.authorMehta, Ushmaen_ZA
dc.contributor.authorClerk, Christineen_ZA
dc.contributor.authorAllen, Elizabethen_ZA
dc.contributor.authorYore, Mackensieen_ZA
dc.contributor.authorSevene, Esperancaen_ZA
dc.contributor.authorSinglovic, Janen_ZA
dc.contributor.authorPetzold, Maxen_ZA
dc.contributor.authorMangiaterra, Vivianaen_ZA
dc.contributor.authorElefant, Elizabethen_ZA
dc.contributor.authorSullivan, Franken_ZA
dc.contributor.authorHolmes, Lewisen_ZA
dc.contributor.authorGomes, Melbaen_ZA
dc.date.accessioned2015-11-18T04:00:43Z
dc.date.available2015-11-18T04:00:43Z
dc.date.issued2012en_ZA
dc.description.abstractBACKGROUND: 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.identifier.apacitationMehta, 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/11427/15092en_ZA
dc.identifier.chicagocitationMehta, 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/11427/15092en_ZA
dc.identifier.citationMehta, 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.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
dc.identifier.urihttp://hdl.handle.net/11427/15092
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2393-12-89
dc.identifier.vancouvercitationMehta 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.language.isoengen_ZA
dc.publisherBioMed Central Ltden_ZA
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution Licenseen_ZA
dc.rights.holder2012 Mehta et al.; licensee BioMed Central Ltd.en_ZA
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en_ZA
dc.sourceBMC Pregnancy and Childbirthen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcpregnancychildbirth/en_ZA
dc.subject.otherPregnancy Registryen_ZA
dc.subject.otherCongenital anomalyen_ZA
dc.subject.otherPharmacovigilanceen_ZA
dc.subject.otherTeratogenicityen_ZA
dc.subject.otherDrug exposureen_ZA
dc.subject.otherAntiretroviralsen_ZA
dc.subject.otherAntimalarialsen_ZA
dc.subject.otherBirth defectsen_ZA
dc.subject.otherNeonatesen_ZA
dc.subject.otherSafetyen_ZA
dc.subject.otherResource-limited settingsen_ZA
dc.titleProtocol for a drugs exposure pregnancy registry for implementation in resource-limited settingsen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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