ISRCTN86353884.

Trial name or title	"Co‐Artemether in pregnancy ‐ a pilot study (Thailand)"
Methods	Randomized controlled trial
Participants	Inclusion criteria: pregnant women with uncomplicated falciparum or mixed infection in second or third trimester who have failed after a course of quinine for 7 days; attend the Shoklo Malaria Research Unit AnteNatal Clinics regularly; agree to deliver at the Shoklo Malaria Research Unit Exclusion criteria: splenectomy; known chronic disease (cardiac, renal, hepatic); known haemoglobinopathy; known hepatic or renal impairment; inability to follow AnteNatal Clinics consultation; history of alcohol or narcotic abuse; inability to tolerate oral treatment; severe and complicated malaria; known hypersensitivity to artemisinin derivatives; taking any drug inhibiting the cytochrome enzyme CYP3A4 or drug that is metabolized by cytochrome enzyme CYPD or family; history of sudden death or of prolongation of QTc interval on electrocardiogram; cardiac arrytyhmia, congestive cardiac failure, or bradycardia accompanied by reduced left ventricular function; intake of drugs that prolong QTc interval
Interventions	1. Artesunate: 50 mg tablets (2 mg/kg/day) for 7 days 2. Co‐artemether (20/120 mg artemether/lumefantrine): 4 tablets twice a day for 3 days with 200 mL chocolate milk at each dose
Outcomes	1. PCR‐adjusted parasitological cure at day 42 or at delivery, depending on which occurs last 2. Gametocyte carriage 3. Pharmaokinetic parameters 4. Histopathology examination (presence of parasites, pigments, monocytes infiltrations, and other placental changes) of the placenta
Starting date	6 February 2004 Anticipated end date: 1 January 2008
Contact information	Dr Melba Gomes (gomesm@who.int), World Health Organization, Switzerland
Notes	Location: Thailand Registration number: ISRCTN86353884 Source of funding: NICEF/UNDP/World Bank/WHO – Special Programme for Research and Training in Tropical Diseases (TDR)

PCR: polymerase chain reaction.