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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201202000272122 |
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Date of registration:
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06/01/2011 |
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Primary sponsor: |
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Public title:
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Intermittent preventive treatment with sulfadoxine-pyrimethamine versus intermittent screening and treatment of malaria in pregnancy
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Scientific title:
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Intermittent preventive treatment with sulfadoxine-pyrimethamine versus intermittent screening and treatment of malaria in pregnancy |
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Date of first enrolment:
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2009-10-01 |
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Target sample size:
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5000 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201202000272122 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Permuted block randomisation; block size is 10; not variable,
llocation was determined by the holder of the sequence who is situated off site,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Harry
Tagbor |
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Address:
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Kumasi
Ghana |
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Telephone:
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+233 *********** |
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Email:
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Harry.Tagbor@lshtm.ac.uk |
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Affiliation:
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London School of Hygiene & Tropical Medicine, UK |
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Name:
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Manuela
Claite |
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Address:
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London
United Kingdom |
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Telephone:
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+44 207 299 4710 |
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Email:
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Manuela.Claite@lshtm.ac.uk |
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Affiliation:
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London School of Hygiene & Tropical Medicine, UK |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Presence of a first or second pregnancy.
2. Gestation between 16 to 30 weeks inclusive at first booking as determined by symphysio-fundal measurements.
3. Provision of written informed consent to join the trial.
4. Residence in the study area and intention to stay in the area for the duration of the pregnancy.
Exclusion criteria: 1. Absence of informed consent.
2. An intention to leave the study area before delivery.
3. A history of sensitivity to sulphonamides.
4. Clinical AIDS or known HIV positivity.
5. Presence of any systemic illness likely to interfere with interpretation of the results of the trial.
Age minimum:
16 Year
Age maximum:
45 Year
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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Low birth weight
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Maternal anaemia
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Placental malaria
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Secondary Outcome(s)
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Acceptability of each approach by pregnant women and antenatal clinic staff
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Adverse outcome of pregnancy ? abortions, still births and neonatal deaths.
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Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted.
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Episodes of clinical malaria
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Feasibility and costs of each approach to the control of malaria in pregnancy
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Maternal anaemia
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Occurrence of congenital abnormalities
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Peripheral blood parasitaemia
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Serious adverse events in the mother
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Secondary ID(s)
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NCT01084213
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Source(s) of Monetary Support
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EDCTP
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