@article{fdi:010060536,
  title = {{P}robabilistic record linkage for monitoring the safety of artemisinin-based combination therapy in the first trimester of pregnancy in {S}enegal},
  author = {{D}ellicour, {S}. and {B}rasseur, {P}hilippe and {T}horn, {P}. and {G}aye, {O}. and {O}lliaro, {P}. and {B}adiane, {M}. and {S}tergachis, {A}. and ter {K}uile, {F}. {O}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {T}here are insufficient data on the safety in early pregnancy of the artemisinins, a new class of antimalarials. {A}ssessment of drug teratogenicity requires large sample sizes for an adequate risk-benefit assessment. {T}here is currently limited pharmacovigilance infrastructure in malaria-endemic countries. {M}onitoring drug safety in early pregnancy is especially challenging, as it requires early pregnancy detection to assess any potential increased risk of miscarriage, prospective follow-up to reduce recall and survival biases, and accurate data on gestational age assessment. {R}ecord linkage approaches for pregnancy pharmacovigilance using routinely generated health records could be a pragmatic and cost-effective approach for pharmacovigilance in early pregnancy, but has not been evaluated in resource-poor settings. {O}bjective {O}ur objective was to assess the feasibility of record linkage using routinely collected healthcare data as a pragmatic means of monitoring the safety in early pregnancy of artemisinin-based combination therapies ({ACT}s) in {S}enegal. {M}ethods {D}ata (2004-2008) from paper-based registers from outpatient clinics, antenatal care services ({ANC}) and the delivery unit from the {S}t {J}oseph dispensary in {M}lomp, south-western {S}enegal, were entered into databases. {R}ecord linkage based on a probabilistic matching approach was used to identify pregnancies exposed to {ACT}s in the first trimester of pregnancy. {T}wo record linkage software packages ({L}ink-{P}lus and {FRIL}) were compared and output data were reviewed independently by two investigators. {R}esults {I}nformation on 685 pregnancies was extracted, 536 of which were from the geographic catchment area and eligible for record linkage; 94.6 % of them resulted in live births, 2.6 % in stillbirths and 2.8 % in miscarriages. {M}ajor congenital malformations were identified in 1.6 % of births. {S}eventy-three and 75 true matches between pregnancy outcome and the outpatient treatment registers were identified by two different record linkage software packages, respectively. {R}ecord linkage identified seven exposures to {ACT}s in the first trimester, all of which resulted in normal live-births. {C}onclusion {P}robabilistic record linkage is a potentially cost-effective method to assess the safety of antimalarials in early pregnancy in resource-constrained settings to assess increased risk of overall birth defects, and stillbirths in settings with good existing health records and well defined target populations.},
  keywords = {{SENEGAL}},
  booktitle = {},
  journal = {{D}rug {S}afety},
  volume = {36},
  numero = {7},
  pages = {505--513},
  ISSN = {0114-5916},
  year = {2013},
  DOI = {10.1007/s40264-013-0059-1},
  URL = {https://www.documentation.ird.fr/hor/fdi:010060536},
}