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Table 3 Safety outcomes: maternal adverse events and pregnancy outcomes in women exposed to artemisinin compounds: Descriptive studies.

From: The safety of artemisinins during pregnancy: a pressing question

Study site, year Ref Antimalarial treatment N (% Follow-up) Outcomes of interests   
    Maternal Safety Pregnancy outcomes  
     Overall 1 st trimester exposures
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 1 st 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
  1. * One maternal death was due to severe malaria and anaemia, the other died of causes unrelated to malaria.
  2. ** For 1 maternal death the exposure status could not be confirmed; verbal autopsies indicate that the deaths were due to postpartum haemorrhage.
  3. 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