Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
22/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melba Gomes

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A30248

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Artesunate

Primary outcome measures

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

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

Overall trial start date

10/11/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women
2. Consent of patient or parent/guardian
3. Participation in survival benefit of early treatment with rectal artesunate

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

684

Participant exclusion criteria

1. Males
2. Non pregnant female enrolled into study ISRCTN83979018
3. Absence of informed consent from patient or parent/guardian

Recruitment start date

10/11/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Bangladesh

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Commission (Belgium)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Funder name

WHO Global Malaria Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

US Agency for International Development (USAID) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Irish Aid (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Karolinska Institutet (Sweden)

Alternative name(s)

Karolinska Institute, KI

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Sall Family Foundation (USA)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

University of Oxford Clinical Trial Service Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes