Condition category
Infections and Infestations
Date applied
27/01/2010
Date assigned
13/05/2010
Last edited
21/07/2011
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 Oumou Maiga

ORCID ID

Contact details

DNS-Mali
Bamako
BP:23
Mali

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in Mali: an open randomised controlled trial

Acronym

Study hypothesis

We hypothesised that intermittent preventive treatment (IPT)-three doses will be as efficacious as IPT-two doses of sulfadoxine-pyrimethamine (SP).

Ethics approval

Ethical committee of Faculty of Medicine, Pharmacy and Odonto-stomatology, University of Bamako approved on the 31st March 2006

Study design

Open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Dr Kassoum Kayentao at kayentao@mrtcbko.org to request a patient information sheet

Condition

Malaria during pregnancy

Intervention

Through an open label block randomisation (block size of 20); women were assigned to receive one of the treatment regimens (two or three doses of SP). One treatment dose was 1500 mg of sulfadoxine and 75 mg of pyrimethamine. Sequence of dosing admistration was as follows:
1. Women in the three-doses received the first dose between the 4th - 6th month of gestation, the second dose between 5th - 7th month of gestation, and the third dose no later that the 8th month of gestation
2. Women in the two-dose group received the first dose between the 4th - 6th month of gestation and the second dose no later than the 8th month of gestation. Doses were administered at least one month apart.

All drugs were administered directly by the study team and women were observed for 30 minutes following dosing. Study participants were asked to avoid self medication of anti-malrials other than the study medication and to return to the clinic for scheduled monthly assessment or any unscheduled sick visits. Women received ferrous sulphate (200 mg containing 60 mg of iron) and folic acid (0.4 mg) daily starting two weeks after each SP dosing as recommended by the Ministry of Health.

If malaria was diagnosed during subsequent visits, oral quinine was given 600 mg three times a day over 7 consecutive days.

Intervention type

Drug

Phase

Phase IV

Drug names

Sulfadoxine-pyrimethamine

Primary outcome measures

Placental malaria. Placental blood was collected from the maternal side of the placenta (after cleaning using filter paper before cutting with cleaned lancet) for thick blood smear for parasitaemia detection.

Secondary outcome measures

1. Low birth weight. Gestational age at delivery was assessed using the Ballard score, and infants were weighed using a digital scale within 24 hours of delivery to measure the incidence of low birth weight.
2. Maternal anaemia. Following delivery, haemoglobin concentration was measured by HemoCue® (Hemocue 201: Anglholm, Sweden) and peripheral parasitaemia was assessed by peripheral blood smear.

Overall trial start date

21/04/2006

Overall trial end date

22/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 14 to 45 years, female pregnant women
2. Gestational age between 16 and 24 weeks
3. Provide consent form
4. Not having chronic disease
5. Willing to terminate the study and follow study conditions

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

406 in each treatment arm (812 in total)

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

21/04/2006

Recruitment end date

22/02/2010

Locations

Countries of recruitment

Mali

Trial participating centre

DNS-Mali
Bamako
BP:23
Mali

Sponsor information

Organisation

National Direction of Health (Mali)

Sponsor details

Tomikorobougou
Bamako
BP:23
Mali

Sponsor type

Government

Website

http://dnsmali.net

Funders

Funder type

Government

Funder name

National Direction of Health (Mali)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21765069

Publication citations

  1. Results

    Diakite OS, Maiga OM, Kayentao K, Traoré BT, Djimde A, Traoré B, Diallo M, Traoré M, Ongoiba A, Doumtabé D, Doumbo S, Traoré MS, Dara A, Guindo O, Karim DM, Coulibaly S, Bougoudogo F, Ter Kuile FO, Danis M, Doumbo OK, Superiority of 3 over 2 doses of intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria during pregnancy in mali: a randomized controlled trial., Clin. Infect. Dis., 2011, 53, 3, 215-223, doi: 10.1093/cid/cir374.

Additional files

Editorial Notes