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.: PACTR201308000543272 Date of Approval: 29/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of intermittent screening and treatment (IST) of malaria in pregnancy in South East Nigeria
Official scientific title Intermittent preventive treatment versus intermittent screening and treatment of malaria in pregnancy
Brief summary describing the background and objectives of the trial Intermittent preventive treatment of malaria during pregnancy(IPTp) with sulphadoxine-pyrimethamine (SP) is currently recommended by the WHO as part of a package of interventions; insecticide-treated nets and effective case management. Recent reports indicate a decline in malaria incidence and an increasing spread resistance to SP. This trial aims to determine if intermittent screening and treatment at scheduled antenatal clinic visits is non-inferior to IPTp in protecting them from anaemia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/07/2013
Actual trial start date 23/10/2013
Anticipated date of last follow up 31/10/2014
Actual Last follow-up date 05/12/2014
Anticipated target sample size (number of participants) 460
Actual target sample size (number of participants) 459
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 (fixed block size 10) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intermittent preventive treatment of malaria in pregnancy (IPTp) with sulphadoxine-pyrimethamine 1500mg sulphadoxine and 75mg pyrimethamine Single dose Study women will receive at least two doses of Sulfadoxine-pyrimethamine during their pregnancy, one at each of the recommended ante-natal visits during the second and third trimester. 230 Active-Treatment of Control Group
Experimental Group Intermittent screening and treatment of malaria in pregnancy (IST) with artemether-lumefantrine 80mg artemether and 480mg lumefantrine twice daily 3 days Intermittent screening of study women using rapid diagnostic test and treatment of those who are RDT positive during ante-natal clinic visits in the second and third trimesters with arthemether-lumefantrine. 230
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnancy (16-24 weeks gestation) confirmed at first booking Willing to have supervised delivery Permanent residence within the study area Haemoglobin < 6.0 g/dl or haematocrit of <18% Presence of malaria requiring parenteral medication or parasite density ¿ 100,000/mm3 of blood. Past obstetric and medical history that will adversely affect the evaluation of outcomes. A prior dose of SP-IPTp Sensitivity to SP, lumefantrine or an artemisinin An illness requiring hospital admission. Known G6PD deficiency to exclude women at risk of haemolytic anaemia. Women who are known to be HIV infected before enrollment will not be recruited because, according to World Health Organization (WHO) and national recommendations, they should receive 3 (rather than 2) IPTp doses. Failure to meet any of the inclusion criteria stated above. 15 Year(s) 49 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 11/04/2013 Cross River State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Calabar Nigeria
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 11/04/2013 Cross River Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
DEPARTMENT OF CLINICAL GOVERNANCE,SERVICOM & E-HEALTH, MINISTRY OF HEALTH, 2ND FLOOR ROOM 17 CALABAR Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Prevalence of severe maternal anaemia (Hb < 8g/dl) of gestation At enrollment/2nd trimester visit 36-40 weeks of gestation
Secondary Outcome Prevalence of low birth weight (< 2500g) Within 7 days of delivery
Secondary Outcome Prevalence of maternal anaemia (Hb < 11g/dl) At enrollment/2nd trimester visit 36-40 weeks of gestation
Secondary Outcome Prevalence of placental malaria At delivery
Secondary Outcome Prevalence and density of microscopical and sub-microscopical gametocytamia At all scheduled ante-natal visits At delivery
Secondary Outcome Prevalence and density of maternal parasitaemia At all scheduled ante-natal visits At delivery At 6 weeks post-delivery visit
Secondary Outcome Congenital anomalies in live births At delivery
Secondary Outcome Prevalence of neonatal mortality 6 weeks post-delivery
Secondary Outcome Prevalence of maternal mortality All through the study
Secondary Outcome Proportions of spontaneous abortions, intrauterine deaths, stillbirths, and pre-term deliveries All through the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital Calabar 133 Mary Slessor Avenue Calabar 540242 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Calabar Institute of Tropical Diseases Research and Prevention University of Calabar Teaching Hospital, Moore Road Calabar 540242 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Calabar PMB 1115 Calabar Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Prof. Martin Meremikwu Department of Paediatrics, University of Calabar Teaching Hospital Calabar Nigeria
Dr. Michael Pritsch Department of Infectious Diseases & Tropical Medicine, Ludwig-Maximilians University Munich Germany
Dr. Nicole Berens-Riha Department of Infectious Diseases & Tropical Medicine, Ludwig-Maximilians University Munich Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekpereonne Esu ekpereonneesu@gmail.com +2347065810085 Department of Public Health, University of Calabar
City Postal code Country Position/Affiliation
Calabar Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Ekpereonne Esu ekpereonneesu@gmail.com +2347065810085 Department of Public Health, University of Calabar
City Postal code Country Position/Affiliation
Calabar Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Martin Meremikwu mmeremiku@yahoo.co.uk +2348036742377 Department of Paediatrics, University of Calabar Teaching Hospital
City Postal code Country Position/Affiliation
Calabar Nigeria Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information