Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201202000272122 Date of Approval: 06/01/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intermittent preventive treatment with sulfadoxine-pyrimethamine versus intermittent screening and treatment of malaria in pregnancy
Official scientific title Intermittent preventive treatment with sulfadoxine-pyrimethamine versus intermittent screening and treatment of malaria in pregnancy
Brief summary describing the background and objectives of the trial Rationale: The incidence of malaria, including the incidence in pregnant women, is declining in many African countries. Thus, there is a need to re-examine the efficacy and cost effectiveness of giving intermittent preventive treatment with sulphadoxine-pyrimethamine in pregnancy (SP-IPTp) on several occasions during pregnancy, an intervention that is threatened by increasing resistance to SP. Possible alternatives to SP-IPTp need to be explored. This applies especially to areas with highly seas
Type of trial RCT
Acronym (If the trial has an acronym then please provide) WAIST
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 30/06/2010
Actual trial start date 01/10/2009
Anticipated date of last follow up 29/06/2012
Actual Last follow-up date 31/10/2011
Anticipated target sample size (number of participants) 5000
Actual target sample size (number of participants) 5000
Recruitment status Completed
Publication URL http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0132247
Secondary Ids Issuing authority/Trial register
NCT01084213 ClinicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SP-IPTp 1500mg sulphadoxine/75mg pyrimethamine as a single dose 2 to 3 times in the second and third trimesters at 6 to 8 weeks intervals SP-IPTp according to WHO recommendations; women will receive at least two doses of SP during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester. 2500 Active-Treatment of Control Group
Experimental Group IST Artemether (80mg)/Lumefantrine (480mg) twice a day for 3 days 2 to 3 times in the second and third trimesters at 6 to 8 weeks intervals Scheduled intermittent screening by RDT and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester.All participant will be given an LLIN at first attendance and instructions on how to use it. Random home visits will be made to check on net use. Standardised doses of ferrous sulphate and folic acid will be given to all participants 2500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 16 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2009 London School of Hygiene and Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2010 Ministere de l¿Enseignement Superieur et de la Recherche Scientifique-Universite de Bamako
Ethics Committee Address
Street address City Postal code Country
BP 1805 Bamako Mali
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/04/2010 Comité national d'éthique pour la recherche en santé (CNERS)
Ethics Committee Address
Street address City Postal code Country
Ministère de la Santé 03 BP 7009 Ouagadougou 03 Ouagadougou Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Low birth weight At delivery for health facility deliveries Within one week of delivery in case of home deliveries.
Primary Outcome Maternal anaemia At 38 weeks (+/- 2 weeks) of gestation.
Primary Outcome Placental malaria Placenta biopsies to be obtained at delivery
Secondary Outcome Peripheral blood parasitaemia At 38 weeks (+/- 2 weeks) of gestation, at the time of delivery and six weeks later
Secondary Outcome Maternal anaemia At the time of delivery or shortly afterwards
Secondary Outcome Episodes of clinical malaria During the course of the pregnancy
Secondary Outcome Serious adverse events in the mother During the course of the pregnancy
Secondary Outcome Adverse outcome of pregnancy ¿ abortions, still births and neonatal deaths. During the course of the pregnancy
Secondary Outcome Occurrence of congenital abnormalities At delivery
Secondary Outcome Feasibility and costs of each approach to the control of malaria in pregnancy End of study
Secondary Outcome Cost per cases of maternal anaemia (severe and non-severe) and peripheral malaria averted. End of study
Secondary Outcome Acceptability of each approach by pregnant women and antenatal clinic staff End of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Université de Ouagadougou 01 BP 7021Ouagadougou 01 Ouagadougou Burkina Faso
Medical Research and Training Centre BP: 1805 Bamako Mali
Medical Research Council (UK), The Gambia Atlantic Boulevard, Fajara Banjul Gambia
Navrongo Health Research Centre Navrongo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene and Tropical Medicine London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Brian Greenwood, MD London School of Hygiene & Tropical Medicine London United Kingdom
Daniel Chandramohan, PhD London School of Hygiene & Tropical Medicine London United Kingdom
Paul Milligan, PhD London School of Hygiene & Tropical Medicine London United Kingdom
Feiko T Kuile, PhD Liverpool School of Tropical Medicine, UK London United Kingdom
Harry Tagbor, DrPH Kwame Nkrumah University of Science & Technology, School of Medical Sciences, Ghana Kumasi Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Harry Tagbor Harry.Tagbor@lshtm.ac.uk +233 244 41 7701
City Postal code Country Position/Affiliation
Kumasi Ghana London School of Hygiene & Tropical Medicine, UK
Role Name Email Phone Street address
Principal Investigator Brian Greenwood Brian.Greenwood@lshtm.ac.uk +44 (0)20 7299 4707
City Postal code Country Position/Affiliation
London United Kingdom London School of Hygiene & Tropical Medicine, UK
Role Name Email Phone Street address
Public Enquiries Manuela Claite Manuela.Claite@lshtm.ac.uk +44 207 299 4710
City Postal code Country Position/Affiliation
London United Kingdom London School of Hygiene & Tropical Medicine, UK
Role Name Email Phone Street address
Scientific Enquiries Harry Tagbor Harry.Tagbor@lshtm.ac.uk +233 244 41 7701
City Postal code Country Position/Affiliation
Kumasi Ghana London School of Hygiene & Tropical Medicine, UK
REPORTING
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