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 | |||
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 1 ^{st} 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 |