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.: PACTR201612001901313 Date of Approval: 02/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Malaria Prevention in pregnancy in Tanzania
Official scientific title Effectiveness of the combination of dihydroartemisinin and piperaquine for prevention of falciparum malaria during pregnancy in Tanzania
Brief summary describing the background and objectives of the trial About 30 million women living in malaria-endemic areas become pregnant each year. pregnant women are prone to malaria infection due to reduced immunity. High saturation of haplotypes confering resistance to sulfadoxine/pyrimethamine undermine its use in malaria prevention during pregnancy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 02/01/2017
Actual trial start date 02/01/2017
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date 30/06/2017
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1000
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Block randomisation created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intermittent preventive treatment with Dihydroartemisinin/piperaquine Once daily dose Three days Monthly intervention given from second trimester at least three doses 300
Control Group Intermittent prevetive treatment with Sulfadoxine/Pyrimethamine Once dayly dose Single dose Monthly dose given as DOT atleast three doses given from the second trimester 300 Active-Treatment of Control Group
Control Group Daily co-trimoxazole alone given to HIV infected pregnant women once daily dose throughout the pregnancy term 100 Active-Treatment of Control Group
Experimental Group IPTDihydroartemisinin and piperaquine added to daily cotrimoxazole among HIV infected pregnant women once daily dose Three days IPTp with Dihydroartemisinin and Piperaquine given on monthly basis while co-trimoxazole is taken daily throughout pregnancy time 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Viable pregnancy assessed by UPT ii. Gestational age 16 to 32 weeks (inclusive) determined by fundal height iii. No prior history of IPTp use for current pregnancy iv. Willing to participate and complete the study schedule v. Willing to sign or thumb print informed consent vi. Resident of study area and intending to stay in the area for the duration of the follow-up vii. Willing to deliver at the health facility i. Residence outside study area or planning to move out in the 12 months following enrolment ii. High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity) iii. Severe anemia requiring blood transfusion (Hb ¿ 7.0 g/dL) at enrolment iv. Known allergy or previous adverse reaction to any of the study drugs v. Unable to give informed consent (for example due to mental disability) vi. Previous inclusion in the same study 15 Year(s) 35 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 07/11/2016 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es salaam 11102 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Active or recent placental malaria Measure at delivery
Secondary Outcome ¿ Incidence of malaria infection and clinical malaria during pregnancy, defined as fever or recent history of fever in the presence of malaria parasites; ¿ Prevalence of adverse newborn morbidity at birth, defined as a composite of either preterm delivery (<37 weeks¿ gestation), low birth weight (<2500 g), and, anemia (hemoglobin<11 g/dL) during pregnancy or at delivery will measured during follow up and some soon after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kibiti kibiti health centre Kibiti 61610 Tanzania
Rufiji district utete hospital Coast region 61601 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Sida-MUHAS Upanga West Dar es Salaam 11103 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MUHAS Upanga West Dar es Salaam 11103 Tanzania University
Secondary Sponsor Sida-MUHAS Upnga West Dar es Salaam 11103 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Karolinska Institute Hudinge Stockholm 100 44 Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EULAMBIUS MATHIAS mlugusonlove@gmail.com +255717737496 Upanga West
City Postal code Country Position/Affiliation
Dar es Salaam 11103 Tanzania Assistant Lecturer- MUHAS
Role Name Email Phone Street address
Public Enquiries Mwelecele Malcela headquarters@nimr.or.tz +255222121400 3 Barack Obama Drive
City Postal code Country Position/Affiliation
Dar es Salaam 11102 Tanzania Chairperson Medical Research Committee/National Institute for Medical Researches
Role Name Email Phone Street address
Scientific Enquiries Appolinary Kamuhabwa enali2012@gmail.com +255 784485465 Upanga West
City Postal code Country Position/Affiliation
Dar es Salaam 11103 Tanzania Professor-MUHAS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information