Safety of rectal artesunate in pregnancy - an assessment of pregnancy outcomes in a randomised controlled trial in Bangladesh

ISRCTN	ISRCTN48295733
DOI	https://doi.org/10.1186/ISRCTN48295733
Protocol serial number	A30248
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funders	United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR), European Commission (Belgium), WHO Global Malaria Programme, US Agency for International Development (USAID) (USA), Irish Aid (Ireland), Karolinska Institutet (Sweden), Sall Family Foundation (USA), University of Oxford Clinical Trial Service Unit (UK)

Submission date: 05/04/2005
Registration date: 07/06/2005
Last edited: 22/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	gomesm@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Evaluation of the risks associated with the use of artesunate in pregnancy in comparison to placebo. This study follows up pregnant women exposed to treatment within a larger trial: ISRCTN83979018 - Evaluate impact of rectal artesunate on resolution of severe malaria and mortality (Bangladesh).
Ethics approval(s)	Ethics approval was obtained on 10.11.03 from the Secretariat Committee on Research Involving Human Subjects and (continuing review) on 19.10 2005 from the World Health Organization (WHO) Ethics Committee.
Health condition(s) or problem(s) studied	Artesunate use in pregnancy
Intervention	A single dose of either 400 mg artesunate suppository or an identical placebo suppository is given.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	684
Key inclusion criteria	1. Pregnant women 2. Consent of patient or parent/guardian 3. Participation in survival benefit of early treatment with rectal artesunate
Key exclusion criteria	1. Males 2. Non pregnant female enrolled into study ISRCTN83979018 3. Absence of informed consent from patient or parent/guardian
Date of first enrolment	10/11/2003
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

Bangladesh
Switzerland

Study participating centre

20, Avenue Appia

Geneva -27
CH 1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan