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

Mehta, Ushma (författare)
Clerk, Christine (författare)
Allen, Elizabeth (författare)
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Yore, Mackensie (författare)
Sevene, Esperança (författare)
Singlovic, Jan (författare)
Petzold, Max, 1973 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin,Akademistatistik,Institute of Medicine,Centre for Applied Biostatistics
Mangiaterra, Viviana (författare)
Elefant, Elizabeth (författare)
Sullivan, Frank M (författare)
Holmes, Lewis B (författare)
Gomes, Melba (författare)
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 (creator_code:org_t)
2012-09-03
2012
Engelska.
Ingår i: BMC pregnancy and childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 12
Relaterad länk:
https://gup.ub.gu.se... (primary) (free)
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https://bmcpregnancy...
https://gup.ub.gu.se...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Nyckelord

Pregnancy Registry
Congenital anomaly
Pharmacovigilance
Teratogenicity
Drug exposure
Antiretrovirals
Antimalarials
Birth defects
Neonates
Safety
Resource-limited settings

Publikations- och innehållstyp

ref (ämneskategori)
art (ämneskategori)

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