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Table 4 Ongoing Studies (Information extracted from Malaria in Pregnancy (MiP)* Database [42] on 05/02/2007).

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

Study Setting Design & Drug Regimen Outcome Status
(start date-completion date)
Safety/Efficacy prevention trial in pregnancy
Ifakara, Tanzania CDC/IHRDC-IMPACT Randomised open label, n = 1200 (400 per arm)
IPT p
Control: SP 2 doses
Intervention:
1. SP monthly
2. SP+artesunate monthly
1°: Placental parasitaemia and AEs
2°: Maternal illness and parasitaemia at delivery, birth outcome (BW, Gestational age, foetal and infant health), childhood developmental milestones
Recruitment concluded; ongoing follow up (01/03-ongoing)
Safety/Efficacy Treatment trial in Pregnancy
ANC at Muheza Hospital, Tanzania GMP Randomised open label, target (Phase III)
n = 350 2nd or 3rd trimesters
Control: SP
Intervention: SP+amodiaquine, Amodiaquine+artesunate, Chloroporguanil-dapsone
1°: Treatment failure at day 28; Treatment outcome (parasite/fever clearance, parasite recrudescence)
2°: Foetal viability and birth outcomes (preterm delivery, foetal death, perinatal/neonatal mortality, neonatal abnormality); maternal AE (hypoglycaemia)
Recruitment completed (01/04–07/06)
Shoklo Malaria Research Unit (SMRU) ANC, Thailand UNICEF-UNDP-World Bank-WHO-TDR Randomized intervention trial
n = 250 2nd or 3rd trimesters Group 1: Artesunate
Group 2: Co-artemether (artemether/lumefantrine)
1°: Treatment outcome at day 42 or at delivery (parasite/fever clearance, parasite recrudescence)
2°:Gametocyte carriage; pharmacokinetic parameters; histo-pathology examination of the placenta
Currently recruiting (06/02/2004–31/12/2008)
Bangladesh
WHO
Randomised controlled trial
n = 684
Control: placebo rectal capsule
Intervention: Artesunate rectal capsule
Pregnancy outcomes Currently recruiting (10/11/2003-ongoing)
Malawi; Prof Meshnick, UNC Randomised open label, n = 141 2nd or 3rd trimesters Control: SP
Intervention: SP+artesunate or SP+azithromycin
1°: Parasitological failure rates; parasite clearance time; fever clearance times and incidence rate of adverse events
2°: Prevalence rate of abortions; still births; peripheral parasitaemia at delivery; placental malaria and of maternal anaemia
Recruitment completed (09/2003–10/2005)
Efficacy/Pharmacokinetic trial in Pregnancy
Mozambique
UCT, South Africa
Non-Randomized openLabel, target n = 30 2nd or 3rd trimester pregnant
HistoricalControl
Intervention: SP+artesunate
1°: Pharmacokinetic parameters
2°: gametocyte carriage, maternal AE & birth outcomes
Currently recruiting (03/2006–09/2008)
Kinshasa, DRC, NIH-NICHD Dose-equivalence trial: part of investigational new drug application
n = 60 2nd or 3rd trimester
Control: SP
Intervention: Artesunate-mefloquine combinations
Pharmacokinetic parameters Recruitment completed (07/2005–12/2005)
Pharmacovigilance: Post-marketing surveillance
Tanzania, CDC Pharmacovigilance surveillance system: part of a large ongoing study to look at district wide use of ACTs 1st trimester
Control: SP
Intervention: SP+Artesunate
Pregnancy outcome and status of child Ongoing (2005–2007)
A partnership between Novartis WHO-TDR and the Government of Zambia. [43] Pregnancy Registry
Prospective active surveillance cohort.
Expected n = 1600
Control: SP
Intervention: artemether-lumefantrine
Maternal and neonatal outcomes examined Ongoing (2005)
  1. * MiP is a consortium of experts in the field of malaria funded by the Bill and Melinda Gates Foundation to review current research and develop future research strategy for malaria in pregnancy. One of the key objectives of MiP is to create a database containing all published and unpublished research and a trial registry on malaria in pregnancy.
  2. Abbreviations: ACT: artemisinin combination therapy; AE: adverse events; ANC: antenatal care; BW: birthweight; CDC: Centers for Disease Control & Prevention; GMP: Gates Malaria Partenership; DRC: Democratic Republic of the Congo; IHRDC: Ifakara Health Research and Development Centre; IPTp: intermittent presumptive treatment for pregnancy; NIH-NICHD: National Institutes of Health-The National Institute of Child Health and Human Development; RCT: randomized controlled trials; SP: sulphadoxine-pyrmethamine; TBB: Thai-Burmese Border; UNC: University of North Carolina; UCT: University of Cape Town; WHO-TDR: World Health Organization – The Special Programme for Research and Training in Tropical Diseases