Safety of rectal artesunate in pregnancy - an assessment of pregnancy outcomes in a randomised controlled trial in Bangladesh
Completed
- Conditions
- Artesunate use in pregnancyInfections and InfestationsMalaria
- Registration Number
- ISRCTN48295733
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 684
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
1. Males
2. Non pregnant female enrolled into study ISRCTN83979018
3. Absence of informed consent from patient or parent/guardian
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Proportion of anomalies in live-born, proportion of stillborn and late foetal deaths (artesunate versus placebo)<br>2. Determination of effect on foetal viability in second and third trimester and inadvertent exposures in first trimester (artesunate and placebo)<br>3. Determination of neonatal and maternal mortality (artesunate versus placebo)<br>4. Assessment of developmental delays (artesunate versus placebo)<br>5. Determination of proportion of children with low birth weight (artesunate versus placebo) in the subgroup of patients assessed prospectively