Observational studyBMC pregnancy and childbirth2014
Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform.
Observational study in BMC pregnancy and childbirth, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Estimating the Prevalence of Prescribed Medication Use in Pregnancy with a Systematic Review and Meta-analysis.Drug safety · 2026Pooled it
- Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.Drug safety · 2024Article
- Determining antenatal medicine exposures in South African women: a comparison of three methods of ascertainment.BMC pregnancy and childbirth · 2022Article
- Drug related adverse pregnancy outcomes at a tertiary care hospital from the foothills of Himalayas: A Prospective observational study.Journal of family medicine and primary care · 2021Article
- Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso.Drug design, development and therapy · 2020Observational
- First trimester medication use in pregnancy in Cameroon: a multi-hospital survey.BMC pregnancy and childbirth · 2018Article
- Safety Profile of Drug Use During Pregnancy at Peripheral Health Centres in Burkina Faso: A Prospective Observational Cohort Study.Drugs - real world outcomes · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is limited safety information on most drugs used during pregnancy. This is especially true for medication against tropical diseases because pharmacovigilance systems are not much developed in these settings. The aim of the present study was to demonstrate feasibility of using Health and Demographic Surveillance System (HDSS) as a platform to monitor drug safety in pregnancy.
methodsPregnant women with gestational age below 20 weeks were recruited from Reproductive and Child Health (RCH) clinics or from monthly house visits carried out for the HDSS. A structured questionnaire was used to interview pregnant women. Participants were followed on monthly basis to record any new drug used as well as pregnancy outcome.
results1089 pregnant women were recruited; 994 (91.3%) completed the follow-up until delivery. 98% women reported to have taken at least one medication during pregnancy, mainly those used in antenatal programmes. Other most reported drugs were analgesics (24%), antibiotics (17%), and antimalarial (15%), excluding IPTp. Artemether-lumefantrine (AL) was the most used antimalarial for treating illness by nearly 3/4 compared to other groups of malaria drugs. Overall, antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome. Iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth (OR 0.1; 0.08-0.3).
conclusionAlmost all women were exposed to medication during pregnancy. Exposure to iron and folic acid had a beneficial effect on pregnancy outcome. HDSS proved to be a useful platform to establish a reliable pharmacovigilance system in resource-limited countries. Widening drug safety information is essential to facilitate evidence based risk-benefit decision for treatment during pregnancy, a major challenge with newly marketed medicines.
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Registered trials
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