Protocol for a drugs exposure pregnancy registry for implementation in resource-limited settings
BMC pregnancy childbirth
; 12(89): 1-13, set 3. 2012. tab, ilus, graf
Article
in English
| RSDM
| ID: biblio-1526611
Responsible library:
MZ1.1
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 improves maternal and neonatal care and also provide much needed information on the safety of medicines in pregnancy
Full text:
Available
Collection:
National databases
/
MZ
Database:
RSDM
Main subject:
Smith-Lemli-Opitz Syndrome
/
Pharmacovigilance
Limits:
Female
/
Humans
/
Pregnancy
Language:
English
Journal:
BMC pregnancy childbirth
Year:
2012
Document type:
Article
Institution/Affiliation country:
Centre de référence sur les agents tératogènes/FR
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Centre for applies biostatistics, department of medicine, sahlgrenska academy, university of gothenburg/SE
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Data management consultant/CZ
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Department of epidemiology and disease control, school of public health/GH
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Department of pharmacology, eduardo mondlane university, manhiça foudation,/MZ
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Division of clinical pharmacology, department of medicine, university of cape town/ZA
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Genetics Unit, massachusetts general hospital for children/US
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Harrington house/GB
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Independent pharmacovigilance consultant/ZA
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Stanford university school of medicine/US