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 -
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en_ZA |