Skip to main content

Table 1 Description of the studies included in the review on the use of artemisinin in pregnancy.

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

  1. * 2nd and 3rd trimesters only
  2. §100% symptomatic/febrile
  3. Abbreviation: ADR: adverse drug reaction; AE: adverse event; ECG: electrocardiograph; IM: intramuscular injection; NR: not reported; Q: quinine; A: artemisinin derivative; A+M: artesunate+mefloquine; TBB: Thai-Burmese border