Prevention of malaria during pregnancy: intermittent preventive treatment with two versus three doses of sulfadoxine-pyrimethamine
| ISRCTN | ISRCTN74189211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74189211 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2010
- Registration date
- 13/05/2010
- Last edited
- 21/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Oumou Maiga
Scientific
Scientific
DNS-Mali
Bamako
BP:23
Mali
Study information
| Study design | Open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Dr Kassoum Kayentao at kayentao@mrtcbko.org to request a patient information sheet |
| 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 |
| Study objectives | We hypothesised that intermittent preventive treatment (IPT)-three doses will be as efficacious as IPT-two doses of sulfadoxine-pyrimethamine (SP). |
| Ethics approval(s) | Ethical committee of Faculty of Medicine, Pharmacy and Odonto-stomatology, University of Bamako approved on the 31st March 2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sulfadoxine-pyrimethamine |
| Primary outcome measure | 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 study start date | 21/04/2006 |
| Completion date | 22/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 406 in each treatment arm (812 in total) |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 21/04/2006 |
| Date of final enrolment | 22/02/2010 |
Locations
Countries of recruitment
- Mali
Study participating centre
DNS-Mali
Bamako
BP:23
Mali
BP:23
Mali
Sponsor information
National Direction of Health (Mali)
Government
Government
Tomikorobougou
Bamako
BP:23
Mali
| Website | http://dnsmali.net |
|---|---|
"ROR" |
https://ror.org/00j73mn11 |
Funders
Funder type
Government
National Direction of Health (Mali)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No |
