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.: PACTR202408866715915 Date of Approval: 02/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of multiple doses of intermittent preventive treatment with Sulphadoxine-Pyrimethamine by directly observed therapy versus none directly observed therapy in parturient at Jos University Teaching Hospital.
Official scientific title Effectiveness of multiple doses of intermittent preventive treatment with Sulphadoxine-Pyrimethamine by directly observed therapy versus none directly observed therapy in parturient at Jos University Teaching Hospital.
Brief summary describing the background and objectives of the trial Malaria in pregnancy remains a public health burden. Intermittent Preventive Treatment of malaria during Pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) is a main intervention to prevent malaria during pregnancy. In the past, a systematic review of clinical trials had advocated for the intake of two doses to effectively reduce the likelihood of adverse maternal and fetal outcomes. Recent evidence indicated that the use of two doses had limited prophylaxis potency. The Evidence Review Group of the WHO has recommended at least three SP doses taken under Directly Observed Therapy(DOT) from second trimester until delivery to help improve maternal and neonatal outcomes. Few studies have been conducted on this revised policy and most centres do not adhere to the DOT. Therefore the aim of this study is to assess the effectiveness of the revised policy by using DOT compared to those without DOT on pregnancy outcome in parturients at Jos University Teaching Hospital (JUTH).
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 Treatment: Drugs
Anticipated trial start date 01/05/2024
Actual trial start date 01/05/2024
Anticipated date of last follow up 30/11/2024
Actual Last follow-up date 30/11/2024
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
Recruitment status Not yet 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
Experimental Group Use of sulphadoxine pyrimethamine as directly observed therapy for pregnant women according to WHO Sulphadoxine (1500mg), Pyrimethamine(75mg) from second trimester till delivery with interval of at least 4 weeks Recruited pregnant women will be given Sulphadoxine Pyrimethamine as early as possible in the second trimester with interval of at least 4 weeks until delivery 56
Control Group Prescription of Sulphadoxine Pyrimethamine for pregnant women Sulphadoxine(1500mg), Pyrimethamine(75mg) From second trimester till delivery with interval of at least 4 weeks Consented pregnant women will be recruited in the second trimester as control group and Sulphadoxine Pyrimethamine will be prescribed for them to take at home ie it is not taken as directly observed therapy 56 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Attends the antenatal clinic at Jos University Teaching Hospital 2. >18 years old 3. Has an uncomplicated singleton term pregnancy 1. Mothers with multiple gestation and sickle cell disease 2. Women with chronic illness such as hypertension, diabetes mellitus, etc. 3. Patients that react to sulphur containing drugs 4. Preterm (<37 wks) labour and delivery 5. Anaemia Adult: 19 Year-44 Year 18 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 11/12/2023 JUTH Health Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Lamingo, Jos Jos 930001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maternal malaria parasitemia and packed cell volume at time of delivery will be the primary outcome measure. At time of delivery
Secondary Outcome The secondary outcome measure will be cord malaria parasitaemia, fetal birth weight and how frequent pregnant women have clinical malaria despite use of Sulphadoxine-Pyrimethamine At delivery and during pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital Lamingo, Jos, Plateau State, Nigeria Jos 930001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akor Andrew Onogwu Lamingo, Jos, Plateau State, Nigeria Jos 930001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akor Andrew Onogwu Lamingo, Jos Jos 930001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Andrew Akor aonogwuandrew@gmail.com 08066391633 Lamingo, Jos
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Aken Alade aken4life@gmail.com +23408069484633 Rayfield, Jos
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Amaka Ocheke amakaocheke@yahoo.com +23408036135114 Rayfield, Jos
City Postal code Country Position/Affiliation
Jos 930001 Nigeria Senior Lecturer at Jos University Teaching Hospital and Chief Consultant at Jos University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will ensure the confidentiality of data by removing any identifying information before sharing it with other researchers. the data will only be used for the purpose of this study and will not be shared with any third parties without explicit consent Informed Consent Form,Statistical Analysis Plan Immediately after completion of research Authorization
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