From: The safety of artemisinins during pregnancy: a pressing question
Study site, year Reference | Study Population | Antimalarial treatment | Primary Outcomes |
---|---|---|---|
Randomized trials* | |||
Nigeria, 1994–1997 [14] | Pregnant women infected with P. falciparum malaria after treatment failure§ | 1) Artemether IM + mefloquine n = 22 2) Artemether IM n = 23 Artemether overall dosage: 3.2–9.6 mg/kg | Parasitaemia at day 28; AEs Foetal outcomes; infant neurodevelopment |
Thailand, 1995–1998 [10] | Pregnant women infected with P. falciparum malaria§ | 1)Quinine n = 29 2)Artesunate+ mefloquine n = 28 Artesunate overall dose: 12 mg/kg | Time to parasite & fever clearance; anaemia; AEs; neurological examination Perinatal assessment; birth outcomes; infant physical and neurological assessment |
TBB, 1995–1997 [12] | Pregnant women with uncomplicated P. falciparum malaria | 1)Quinine n = 42 2)Artesunate+mefloquine n = 66 Artesunate overall dose: 12 mg/kg | Parasite clearance; anaemia; AEs; neurological deficit Birth outcomes; infant developmental milestones |
TBB, 1997–2000 [13] | Pregnant women with uncomplicated P. falciparum malaria | 1)Quinine+clindamycin n = 65 2) Artesunate n = 64 Artesunate overall dose: 12 mg/kg | Treatment failure at day 42 or before delivery; anaemia; AEs Birth outcomes; infant developmental milestones |
TBB, 2001–2003 [11] | Pregnant women with uncomplicated P. falciparum or mixed malaria | 1)Quinine n = 42 2) Artesunate atovaquone-proguanil n = 39 Artesunate overall dose: 12 mg/kg | Fever, parasite clearance; treatment failure at day 63; anaemia; AEs Birth outcomes; infant developmental milestones |
Case series | |||
China, 1976–1980 [15] | Pregnant women infected with P. falciparum or P vivax malaria§ Trimesters (n): 3rd (1), 2nd (5) | Artemisinin IM or Artemether Overall artemisinins dose: 500–900 mg | Therapeutic effects and adverse reactions for mother and child |
TBB, 1992–1996 [17] | Pregnant women with uncomplicated multi-drug resistant P. falciparum or mixed malarial infection Trimesters (n): 3rd & 2nd (74), 1st (16) | Artesunate alone or with mefloquine; or Artemether+mefloquine Overall artemisinins dose: 12–16 mg/kg | Treatment failure at day 42; anaemia; ADR; neurological deficit Birth outcome; infant neurological development |
TBB, 1991–1996 [18] | Pregnant women with uncomplicated multi-drug resistant P. falciparum malarial infection after treatment failure Trimesters (n): 3rd & 2nd (74), 1st (16) | Artesunate alone or with mefloquine; or Artemether+mefloquine Overall artemisinins dose: 12–16 mg/kg | Treatment failure at day 42; anaemia; ADR; neurological deficit Birth outcome; infant neurological development |
TBB, 1992–2000 [16] | Pregnant women with uncomplicated multi-drug resistant P. falciparum or mixed malarial infection Trimesters (n): 3rd (211), 2nd (201), 1st (42) | Artesunate alone or with mefloquine; clindamycin atovaquone-proguanil;or coartemether, artemether IM Overall artemisinins dose: 12–16 mg/kg | Treatment failure at day 42; anaemia; ADR; neurological deficit Birth outcome; infant developmental milestones |
TBB 1999–2001 [19] | Pregnant women with multi-drug resistant P. falciparum or mixed malarial infection Trimesters (n): 3rd & 2nd (24), 1st (3) | Artesunate+atovaquone-proguanil Artesunate overall dose: 12–14 mg/kg | Treatment failure at day 42; parasite clearance; AEs Birth outcomes |
TBB 2000–2001 [20] | Pharmacokinetic study: pregnant women with multi-drug resistant P. falciparum or mixed malarial infection Trimesters (n): 3rd (13) & 2nd (11) | Artesunate+atovaquone-proguanil Artesunate overall dose: 12 mg/kg | Pharmacokinetic parameters; AEs (including ECG); parasite clearance Birth outcomes |
Gambia, 1999 [41] | Pregnant women participating in mass prevention campaign Trimesters (n): 1st (77) | Artesunate + SP Artesunate overall dose: 200 mg | MDA 1° aim: malaria transmission Pregnancy outcomes |
Sudan, 1997–2001 [22] | Pregnant women infected with P. falciparum malaria after treatment failure§ Trimesters (n): 3rd (15), 2nd (12), 1st (1) | Artemether IM Artemether overall dose: 480 mg | Treatment failure at day 28; anaemia; neurological deficit Birth outcomes |
Sudan, 2004–2005 [23] | Pregnant women infected with uncomplicated P. falciparum malaria§ Trimesters (n): 3rd (22), 2nd (10) | Artesunate + SP Artesunate overall dose: 200 mg | Treatment failure at day 28; anaemia Birth outcomes |