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.: PACTR202304768950531 Date of Approval: 04/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Monthly versus three doses malaria chemoprophylaxis in pregnancy at Lautech Teaching Hospital Osogbo, a randomised controlled study
Official scientific title Monthly versus three doses malaria chemoprophylaxis in pregnancy at Lautech Teaching Hospital Osogbo, a randomised controlled study
Brief summary describing the background and objectives of the trial Background: Pregnant women are more susceptible to malaria, which causes serious adverse effects including abortion, low birth weight, preterm delivery and maternal anaemia.. The prevalence of malaria in pregnancy is highest in the first and second trimesters of pregnancy. Younger women tend to have malaria in pregnancy more that their older counterparts likewise first timers and second timers are worst hit in pregnancy than subsequent pregnancy carriers. Intermittent preventive therapy for malaria in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is an effective treatment in reducing the risk of placental malaria, low birth weight (LBW), and severe maternal anaemia, together with long-lasting insecticidal nets (LLINs). It was recommended that this preventive treatment should be given to all pregnant women starting as early as possible in the second trimester. The women should receive at least 3 doses of SP during pregnancy, with successive dose given at least 1 month apart. This policy however does not state the maximum dose to be administered. There is need to further assess if there is any significant benefit in giving monthly or if the three doses are just enough Objective: The aim of this study is to determine and compare the efficacy of 3 doses of IPTp-SP and monthly IPTp-SP among pregnant women as chemoprophylaxis against placenta malaria, low birth weight and preterm birth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Malaria,MALARIA IN PREGNANCY
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date 19/10/2022
Anticipated target sample size (number of participants) 242
Actual target sample size (number of participants) 227
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ARM A 3 doses Arm A received the 3 doses of SP (1st dose between 16 and 24 weeks of gestation, second dose between 24 and 32 weeks of gestation and third dose after 32 weeks of gestation) Arm A received the 3 doses of SP (1st dose between 16 and 24 weeks of gestation, second dose between 24 and 32 weeks of gestation and third dose after 32 weeks of gestation) 117
Control Group ARM B Monthly Arm B received monthly dose of SP. Sulphadoxine-Pyrimethamine (1500mg-75mg) was administered at each dose. Arm B received monthly dose of SP. Sulphadoxine-Pyrimethamine (1500mg-75mg) was administered at each dose. 110 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) All pregnant women who consented irrespective of their age or gravidity (b) Pregnancy at the second trimester but not more than 20weeks (c) No history of allergic reaction to sulphonamides Positive test for VDRL, diabetics, and hypertension (essential or pregnancy induced) (b) Severe anaemia (PCV <20%) (c) Multiple pregnancy as determined by an ultrasound scan report (d) Other severe illness that could require hospitalization. e) Reaction to Sulphonamides Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 64 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 21/05/2021 Research Ethics Committee LAUTECH TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
Idi-Seke, station road Osogbo 234035 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plavental malaria detection and At delivery
Primary Outcome Birth Weight and Low birth weight At Birth
Primary Outcome Gestational Age at delivery and Preterm Births At delivery
Secondary Outcome Neonates' packed cell volume and Anaemia At Birth
Secondary Outcome Maternal Packed Cell Volume and Anaemia At delivery
Secondary Outcome Cord Blood Malaria detection At Delivery
Secondary Outcome Detection and Treatment of Pregnant women for symptomatic Malaria in pregnancy During pregnancy after recruitment till delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAUTECH TEACHING HOSPITAL Idi-Seke, Station Road Osogbo 234035 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded LAUTECH TEACHING HOSPITAL Osogbo 234035 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AYODELE KABIR ALAO LAUTECH TEACHING HOSPITAL OSOGBO 234035 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Daniel Adebode Adekanle LAUTECH TEACHING HOSPITAL OSOGBO 234035 Nigeria
Dr A.O FASANU LAUTECH TEACHING HOSPITAL OSOGBO 234034 Nigeria
Dr A.T. Adeyemo LAUTECH TEACHING HOSPITAL OSOGBO 234035 Nigeria
Dr O.A ALA LAUTECH TEACHING HOSPITAL OSOGBO 234035 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayodele ALAO harlahow@yahoo.com +2348038266123 LAUTECH TEACHING HOSPITAL
City Postal code Country Position/Affiliation
OSOGBO 234035 Nigeria Resident Doctor
Role Name Email Phone Street address
Principal Investigator Adebode Adekanle adekanle2000@yahoo.co.uk +2348035379325 LAUTECH TEACHING HOSPITAL
City Postal code Country Position/Affiliation
OSOGBO 234035 Nigeria Professor
Role Name Email Phone Street address
Public Enquiries ADENIYI FASANU pekun2001@yahoo.co.uk 2348033857553 LAUTECH TEACHING HOSPITAL, IDI-SEKE
City Postal code Country Position/Affiliation
OSOGBO Nigeria CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries TEMITOPE ADEYEMO adeyemoot@gmail.com +2347031287078 LAUTECH TEACHING HOPSITAL,IDISEKE,
City Postal code Country Position/Affiliation
OSOGBO Nigeria CONSULTANT
Role Name Email Phone Street address
Public Enquiries OLUFEMI ALA alaolufemi248@gmail.com 2348036896773 LAUTECH TEACHING HOSPITAL, IDI-SEKE
City Postal code Country Position/Affiliation
OSOGBO Nigeria CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries ADEWUMI TAIWO droluwaseuntaiwo@gmail.com +2348066672064 LAUTECH TEACHING HOSPITAL, IDI-SEKE
City Postal code Country Position/Affiliation
OSOGBO Nigeria RESIDENT DOCTOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data that underlie the results reported in this article after de-identification such as text tables, figures and appendices Informed Consent Form 9 months after Article publication and upto 18 months Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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