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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