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Safety outcomes: maternal adverse events and pregnancy outcomes in women exposed to artemisinin compounds: Descriptive studies. |
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| Study site, year Ref |
Antimalarial treatment |
N (% Follow-up) |
Outcomes of interests |
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| Maternal Safety |
Pregnancy outcomes |
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| Overall |
1st trimester exposures |
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| China, 1976–1980 [15] |
Artemisinin IM or Artemether |
6 (100%) |
No adverse effect |
6 (100%) followed up at 5–9 year |
None |
| TBB, 1992–2000 [16] |
Artesunate alone or with mefloquine; clindamycin atovaquone-proguanil; coartemether, artemether IM |
461 (89%) |
No ADRs (pruritus) Maternal deaths (n = 2)* |
Abortions 4.8% (n = 20) Stillbirth 1.8% (n = 7) Congenital abnormalities 0.8%: anencephaly (n = 1); midline epidermoid cyst (n = 1) |
Abortions 23% (n = 10) |
| TBB 1999–2001 [19] |
Artesunate+atovaquone-proguanil |
27 (100%) |
Symptoms possible ADRs: Headache (42%); muscle/joint pain (30%); abdominal pain (42%); anorexia (40%); nausea (25%); vomiting (10%); rash (15%); dizziness (70%), tinnitus (24%); contraction (15%) and sleep disturbance (8%) |
Neonatal deaths (n = 1) |
Normal deliveries and healthy newborns |
| Gambia, 1999 [41] |
Artesunate + SP |
325 (88%) |
Maternal deaths (n = 1)** |
Stillbirth (n = 11) Congenital abnormalities: umbilical hernia (n = 1); undescended testis; (n = 1) Neonatal deaths (n = 8) |
Not reported |
| Sudan, 1997–2001 [22] |
Artemether IM |
28 (100%) |
NR |
Neonatal deaths (n = 1) |
Normal delivery and healthy newborn |
| Sudan, 2004–2005 [23] |
Artesunate + SP |
32 (100%) |
Giddiness and nausea (13%) Neurological exam. |
Neonatal deaths (n = 1) |
None |
| TOTAL |
123 1st trimester, P. falciparum or mixed malaria 7% to 100% symptomatic 945 artemisinin exposures |
879 (90%) |
3 maternal deaths Neurological exam in 2 studies |
Abortions n = 20 Stillbirths (n = 18) Congenital abnormality: (n = 4) Neonatal deaths (n = 11) 65 (15%) infant followed up to 1 year |
Abortions n = 10 |
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* One maternal death was due to severe malaria and anaemia, the other died of causes unrelated to malaria. ** For 1 maternal death the exposure status could not be confirmed; verbal autopsies indicate that the deaths were due to postpartum haemorrhage. Abbreviation: ADR: adverse drug reaction; AE: adverse event; IM: intramuscular injection; NR: not reported; Q: quinine; A: artemisinin derivative; A+M: artesunate+mefloquine; TBB: Thai-Burmese border | |||||
Dellicour et al. Malaria Journal 2007 6:15 doi:10.1186/1475-2875-6-15 |
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