Malaria in pregnancy Infections and Infestations Plasmodium falciparum malaria, Plasmodium vivax malaria
Conditions
Interventions
SSTp-DHP: (control group): Participants in the 2nd or 3rd trimester will be screened with HRP2-pLDH combination RDT (Pf/Pan First Response®, Premier Medical Corporation Ltd, India) at 1st antenatal vi
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Malaria infection at delivery (peripheral and or placental) detected by RDT, microscopy or polymerase chain reaction (PCR), or placental Histology (active) measured at the time when women deliver, except incidence of malaria which will occur anytime between enrolment and delivery when and if they are positive for malaria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Individual components of composite primary outcome 1. Incidence of malaria infection by species measured by PCR (using dried blood spots) 2. Congenital malaria, defined as parasitaemia in cord or newborn peripheral blood in the first seven days of life detected by smear, RDT or PCR. 3. Composite of spontaneous births resulting in either low birth weight, preterm birth 4. Mean and Low birth weight 5. Mean Gestational age at birth, Preterm delivery (< 37 weeks) measured by using Ballard score 6. Small for gestational age (<10th percentile of WHO recommended reference) 7. Mean maternal haemoglobin and anaemia at 36 weeks and at delivery measured using HemoCue reading 8. Incidence all-cause and malaria clinic visits 9. Cord haemoglobin (Hb) and newborn anaemia 10. Neonatal deaths 11. Perinatal death Tolerability and safety 1. Serious adverse events & adverse events 2. Congenital malformations in the newborn identified at birth and by 6 weeks afterbirth. | — |
Countries
Indonesia
Outcome results
None listed