Table 2 |
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Safety outcomes: maternal adverse events and pregnancy outcomes in women exposed to artemisinin compounds. Randomized trials |
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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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| Nigeria, 1994–1997 [14] |
1) Artemether IM + mefloquine n = 22 2) Artemether IM n = 23 |
45 (100%) |
Minimal, only A+M: abdominal discomfort (9%) and dizziness (9%) |
Neonatal jaundice (n = 2 A & n = 1 A+M) 6 (13%) followed up to 1 year |
| Thailand, 1995–1998 [10] |
1) Quinine n = 29 2) Artesunate+ mefloquine n = 28 |
60 (95%) |
Neurological exam: all normal. Nausea (16%), vomiting (12%), vertigo (12%), tinnitus (18%), and hypoglycaemia (3%) more frequent in Q (p < 0.05). Other no difference: Palpitation (6%), blurring vision (11%). |
Neonatal jaundice (n = 5 Q & n = 1 A+M) 46 (81%) followed up to 1 year |
| TBB, 1995–1997 [12] |
1) Quinine n = 42 2) Artesunate+ mefloquine n = 66 |
108 (85%) |
Neurological exam 1 maternal death* Tinnitus (15%) and dizziness (42%) more frequent in Q (p < 0.05). Headache (21%), nausea (45%), abdominal pain (28%), vertigo (12%), muscle/joint pain (32%), and anorexia (35%) no difference with Q (p > 0.05). |
Abortions (n = 2 A+M) 46 (49%) followed up to 1 year Neonatal deaths (n = 2 A+M & n = 1 Q) |
| TBB, 1997–2000 [13] |
1) Quinine)+ clindamycin n = 65 2) Artesunate n = 64 |
129 (91%) |
Tinnitus (9%) more frequent in Q+C (p < 0.05). Headache (30%), dizziness (41%) nausea
(25%), vomiting (8%), abdominal pain (18%), rash (9%), contractions (35%), muscle/joint
pain (12%), and anorexia (42%) no difference with Q+C (p > 0.05). |
Stillbirths (n = 1 A & n = 1 Q+C) Congenital abnormality: midline epidermoid cyst (n = 1 Q+C) Neonatal deaths (n = 1 A & n = 2 Q+C) 72 (62%) followed up to 1 year |
| TBB, 2001–2003 [11] |
1)Quinine n = 42 2) Artesunate atovaquone-proguanil (AAP) n = 39 |
81 (91%) |
1 maternal death** Tinnitus (24%) more frequent in Q (p < 0.05). |
Stillbirth (n = 1 not specified maternal death) Congenital abnormalities: polythelia (n = 1 AAP); cleft lip & palate (n = 1 AAP); aural atresia (n = 1 Q) Neonatal deaths (n = 1 A & n = 2 Q+C) 59 (78%) followed up to 1 year Developmentally delayed (n = 1 AAP) |
| TOTAL |
No 1st trimester, P. falciparum or mixed malaria 17% to 100% symptomatic 242 artemisinins exposures |
423 (94%) |
2 maternal deaths Neurological exam in 2 studies |
Stillbirths (n = 1 A; n = 1 Q+C & n = 1 unknown) Congenital abnormality: (n = 2 A & n = 2 Q) Neonatal deaths (n = 4 A+M & n = 5 Q) 229 (59%) infant followed up to 1 year |
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¥ Prevalence of possible ADRs are only reported for the artemisinin treatment groups * cause unrelated to malaria (treatment group NR) ** caused by a ruptured liver abscess (treatment group NR) 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 |
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Dellicour et al. Malaria Journal 2007 6:15 doi:10.1186/1475-2875-6-15 |
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