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.: PACTR201808204807776 Date of Approval: 07/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of Dihydroartemisinin-Piperaquine versus Sulphadoxine-Pyrimethamine for malaria prevention in pregnancy
Official scientific title COMPARATIVE EFFICACY OF SULPHADOXINE-PYRIMETHAMINE AND DIHYDROARTEMISININ-PIPERAQUINE FOR INTERMITTENT PREVENTIVE TREATMENT OF MALARIA DURING PREGNANCY: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial BACKGROUND: Malaria in pregnancy is a major public problem and a significant contributor to maternal and perinatal morbidity and mortality. Sulphadoxine-pyrimethamine (SP) is currently the only drug recommended for intermittent preventive treatment of malaria in pregnancy (IPTp). The absence of an alternative drug for individuals that are allergic to SP and the emergence of resistance to SP threatens the gains made by intermittent preventive treatment of malaria in pregnancy using sulphadoxine-pyrimethamine (IPTp-SP). Dihydroartemisinin-piperaquine (DHA-PPQ) is a safe, well-tolerated artemisinin-based combination drug that is effective in the treatment of malaria and has a long-lasting post-treatment prophylactic property. These qualities make DHA-PPQ a good candidate to be evaluated for IPTp. AIMS: This would be an open label randomized control trial to compare the efficacy of sulphadoxine-pyrimethamine versus dihydroartemisinin-piperaquine in the intermittent preventive treatment of malaria in pregnancy at the Federal Teaching Hospital Abakaliki Ebonyi state Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DHA
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria,malaria prevention during pregnancy
Purpose of the trial Prevention
Anticipated trial start date 06/08/2018
Actual trial start date 06/08/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 31/01/2019
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 360
Recruitment status Recruiting
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group SulphadoxinePyrmethamine 3 tablets of sulphadoxine-pyrimethamine(SP) (each tablet contains 500mg Sulphadoxine and 25mg Pyrimethamine) Stat Each participant would receive 3 doses of SP in the course of the pregnancy at a minimum interval of 4 weeks 180 Active-Treatment of Control Group
Experimental Group Dihydroartemisinin Piperaquine DHA 3 tablets of Dihydroartemisinin-Piperaquine once daily (each tablet contains 40mg of Dihydroartemisinin and 320mg of Piperaquine 3 days Each participant will take 3 tablets of Dihydroartemisinin-Piperaquine daily for 3 days from the second trimester of the pregnancy for a total of 3 courses at intervals of at least 4 weeks 180
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pregnant women between 14 weeks and 24 weeks gestation with viable pregnancy. 2. Women who have not received intermittent preventive treatment with sulphadoxine–pyrimethamine during the index pregnancy. 3. Women not allergic to sulphadoxine-pyrimethamine or dihydroartemisinin-piperaquine. 4. Women willing to deliver in the study hospital. 1. Women in the first trimester of pregnancy. 2. HIV positive pregnant women 3. Women allergic to sulphadoxine-pyrimethamine or dihydroartemisini-piperaquine. 4. Women with high-risk pregnancies e.g. medical diseases in pregnancy (sickle cell disease, diabetes mellitus, hypertensive disorders in pregnancy) and multiple gestations. 5. Women who do not consent to the study. Adult: 19 Year-44 Year 19 Year(s) 44 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 15/11/2017 Federal Teaching Hospital Abakaliki Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
FMC Road Abakaliki 480231 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevalence of placental malaria At delivery
Secondary Outcome Incidence of symptomatic malaria, adverse birth outcomes, including spontaneous abortion, stillbirth, low birth weight (<2500 g), and preterm delivery (<37 weeks). During pregnancy and at delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL TEACHING HOSPITAL ABAKALIKI FMC road Abakaliki 480231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Federal Teaching Hospital Abakaliki FMC Road Abakaliki 480231 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chinedu Ifemelumma Ifemelummachinedu@gmail.com +2348033966788 7 Jimetu Street
City Postal code Country Position/Affiliation
Abakaliki 480231 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Vitus Obi veemanx@yahoo.com +2348038884406 FMC Road
City Postal code Country Position/Affiliation
Abakaliki 480213 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Chidiebere Anikwe drchideanikwechristian@gmail.com +2348064165965 FMC Road
City Postal code Country Position/Affiliation
Abakaliki 480231 Nigeria Obstetrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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