Intermittent Screening and Treatment Or intermittent Preventing therapy for the control of Malaria in Pregnancy in Indonesia: an open label cluster randomised controlled superiority trial

iverpool School of Tropical Medicine (UK)0 个研究点目标入组 2,279 人开始时间: 2013年5月8日最近更新: 2019年8月26日

适应症

试验速览

•Pregnant women of any age and gravidity with:
•1. Gestational age 16 to 30 weeks (inclusive) by last menstrual period (LMP) (if available) or fundal height or after quickening
•2. Viable pregnancy (fetal heart sound detected, or other signs of fetal life such as perceived motion of fetus)
•3. Willing to participate and complete the study schedule
•4. Has provided written informed consent
•5. Resident of study area and intending to stay in the area for the duration of the follow-up
•6. Willing to give birth in a study selected health facility (Puskesmas, Polindes or hospital)

•1. Residence outside study area or planning to move out in the 6 months following enrolment
•2. Pre-existing conditions likely to cause complication in the current pregnancy (e.g. hypertension, diabetes, asthma, renal disease, liver disease, any spinal deformity)
•3. Known allergy or previous adverse reaction to any of the study drugs based on information provided by the participant such as development of skin rash, severe nausea and vomiting
•4. Requires cotrimoxazole prophylaxis for opportunistic infection (e.g. for women known to be HIV positive)
•5. Treatment with antimalarials in the last month ( e.g mefloquine, halofantrine, lumafantrine, chloroquine) or last week ( quinine)
•6. Unable to give informed consent (for example due to mental disability)
•7. Severe malaria according to WHO definition requiring parenteral treatment
•8. Family history of sudden death or of congenital prolongation of QTc interval, or known congenital prolongation of the QTc-interval or any known cardiac condition, such as history of symptomatic cardiac arrhythmia, bradycardia or congestive heart failure
•9. Taking medicinal products that are known to prolong QTc interval

发起方

iverpool School of Tropical Medicine (UK)