Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa
NCT ID: NCT03208179
Last Updated: 2022-06-27
Study Results
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Basic Information
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COMPLETED
PHASE3
4680 participants
INTERVENTIONAL
2018-03-29
2020-03-15
Brief Summary
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Detailed Description
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Two exploratory trials in Uganda and Kenya demonstrated that IPTp with DP was superior to IPTp-SP for the prevention of malaria infection in pregnancy. However, neither study was adequately powered to look at adverse birth outcomes. This study is a confirmatory efficacy trial in Malawi, Tanzania and Kenya to determine the efficacy and safety of IPTp with DP alone or in combination with AZ.
This will be a 3-arm trial, superiority, partial blinded, placebo controlled, randomized trial comparing IPTp with SP, versus IPTp with DP alone, and IPTp with DP+AZ with the following hypotheses:
* IPTp with DP is superior to IPTp with SP in preventing adverse pregnancy outcomes.
* The combination of DP with AZ further reduces adverse pregnancy outcomes compared to IPTp with DP alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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IPTp-SP
Stat course of 3 tablets of quality-assured SP (tablets of 500 mg of sulphadoxine and 25 mg of pyrimethamine) at each scheduled antenatal visit
sulphadoxine-pyrimethamine
Women randomised to this intervention will receive stat dose of 3 tablets of 500 mg sulphadoxine and 25 mg of pyrimethamine each (total dose of 1,500mg sulphadoxine and 75mg pyrimethamine) on a single day of clinic visit
IPTp-DP
Dihydroartemisinin-piperaquine \[3 to 5 tablets of DP (tablets of 40 mg of dihydroartemisinin and 320 mg of piperaquine, based on bodyweight) daily for 3 days\] + placebo AZ at each scheduled antenatal visit
dihydroartemisinin-piperaquine
Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin placebo
IPTp-DPAZ
Dihydroartemisinin-piperaquine \[3 to 5 tablets of DP (tablets of 40 mg of dihydroartemisinin and 320 mg of piperaquine, based on bodyweight) daily for 3 days\] + AZ tablet \[1.5g over 3 days as 500mg per day\] at each scheduled antenatal visit.
dihydroartemisinin-piperaquine plus azithromycin
Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin (500mg)
Interventions
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dihydroartemisinin-piperaquine
Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin placebo
sulphadoxine-pyrimethamine
Women randomised to this intervention will receive stat dose of 3 tablets of 500 mg sulphadoxine and 25 mg of pyrimethamine each (total dose of 1,500mg sulphadoxine and 75mg pyrimethamine) on a single day of clinic visit
dihydroartemisinin-piperaquine plus azithromycin
Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin (500mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Viable singleton pregnancy
* Resident of the study area
* Willing to adhere to scheduled and unscheduled study visit procedures
* Willing to deliver in a study clinic or hospital
* Provide written informed consent
Exclusion Criteria
* HIV-positive
* Known heart ailment
* Severe malformations or non-viable pregnancy if observed by ultrasound
* History of receiving IPTp-SP during this current pregnancy
* Unable to give consent
* Known allergy or contraindication to any of the study drugs
16 Years
FEMALE
Yes
Sponsors
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Kamuzu University of Health Sciences
OTHER
Kenya Medical Research Institute
OTHER
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Kilimanjaro Christian Medical Centre, Tanzania
OTHER
University of Copenhagen
OTHER
Centers for Disease Control and Prevention
FED
London School of Hygiene and Tropical Medicine
OTHER
University College, London
OTHER
Tampere University
OTHER
University of Bergen
OTHER
University of Massachusetts, Worcester
OTHER
University of Toronto
OTHER
University of Melbourne
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER
Liverpool School of Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Simon K Kariuki, PhD
Role: PRINCIPAL_INVESTIGATOR
Kenya Medical Research Institute
Frank Mosha, PhD
Role: PRINCIPAL_INVESTIGATOR
Kilimanjaro Christian Medical University College
John Lusingu, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Medical Research
Locations
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Ahero Sud-countyHospital
Ahero, Kisumu County, Kenya
Homa Bay County Hospital
Homa Bay, , Kenya
Rabour Sub-county Hospital
Kisumu, , Kenya
Chikwawa District Hospital
Chikwawa, , Malawi
Mangochi District Hospital
Mangochi, , Malawi
Handeni District Hospital
Handeni, , Tanzania
Korogwe District Hospital
Korogwe, , Tanzania
Countries
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References
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Gore-Langton GR, Madanitsa M, Barsosio HC, Minja DTR, Mosha J, Kavishe RA, Mtove G, Gesase S, Msemo OA, Kariuki S, Otieno K, Phiri KS, Lusingu JPA, Mukerebe C, Manjurano A, Ikigo P, Saidi Q, Onyango ED, Schmiegelow C, Dodd J, Hill J, Hansson H, Alifrangis M, Gutman J, Hunter PJ, Klein N, Ashorn U, Khalil A, Cairns M, Ter Kuile FO, Chico RM. Prevalence and risk factors of curable sexually transmitted and reproductive tract infections and malaria co-infection among pregnant women at antenatal care booking in Kenya, Malawi and Tanzania: a cross-sectional study of randomised controlled trial data. BMJ Public Health. 2024 Sep 18;2(2):e000501. doi: 10.1136/bmjph-2023-000501. eCollection 2024 Dec.
Madanitsa M, Barsosio HC, Minja DTR, Mtove G, Kavishe RA, Dodd J, Saidi Q, Onyango ED, Otieno K, Wang D, Ashorn U, Hill J, Mukerebe C, Gesase S, Msemo OA, Mwapasa V, Phiri KS, Maleta K, Klein N, Magnussen P, Lusingu JPA, Kariuki S, Mosha JF, Alifrangis M, Hansson H, Schmiegelow C, Gutman JR, Chico RM, Ter Kuile FO. Effect of monthly intermittent preventive treatment with dihydroartemisinin-piperaquine with and without azithromycin versus monthly sulfadoxine-pyrimethamine on adverse pregnancy outcomes in Africa: a double-blind randomised, partly placebo-controlled trial. Lancet. 2023 Mar 25;401(10381):1020-1036. doi: 10.1016/S0140-6736(22)02535-1. Epub 2023 Mar 10.
Mtove G, Abdul O, Kullberg F, Gesase S, Scheike T, Andersen FM, Madanitsa M, Ter Kuile FO, Alifrangis M, Lusingu JPA, Minja DTR, Schmiegelow C. Weight change during the first week of life and a new method for retrospective prediction of birthweight among exclusively breastfed newborns. Acta Obstet Gynecol Scand. 2022 Mar;101(3):293-302. doi: 10.1111/aogs.14323. Epub 2022 Feb 13.
Other Identifiers
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16.049
Identifier Type: -
Identifier Source: org_study_id
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