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 |
| Secondary identifying numbers | A30248 |
- 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
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| gomesm@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate |
| Primary outcome measure | 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 study start date | 10/11/2003 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
European Commission (Belgium)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
WHO Global Malaria Programme
No information available
US Agency for International Development (USAID) (USA)
No information available
Irish Aid (Ireland)
No information available
Karolinska Institutet (Sweden)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Sall Family Foundation (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United States of America
University of Oxford Clinical Trial Service Unit (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
