Artesunate use in pregnancy Infections and Infestations Malaria
Conditions
Interventions
A single dose of either 400 mg artesunate suppository or an identical placebo suppository is given.
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women 2. Consent of patient or parent/guardian 3. Participation in survival benefit of early treatment with rectal artesunate
Exclusion criteria
Exclusion criteria: 1. Males 2. Non pregnant female enrolled into study ISRCTN83979018 3. Absence of informed consent from patient or parent/guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this study is a sub-study within a larger trial that has mortality as the main outcome, this should be considered as the same outcome for this trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of anomalies in live-born, proportion of stillborn and late foetal deaths (artesunate versus placebo) 2. Determination of effect on foetal viability in second and third trimester and inadvertent exposures in first trimester (artesunate and placebo) 3. Determination of neonatal and maternal mortality (artesunate versus placebo) 4. Assessment of developmental delays (artesunate versus placebo) 5. Determination of proportion of children with low birth weight (artesunate versus placebo) in the subgroup of patients assessed prospectively | — |
Countries
Bangladesh
Outcome results
None listed