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.: PACTR201610001823405 Date of Approval: 15/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF A HEALTH EDUCATIONAL INTERVENTION ON MALARIA PREVENTIVE BEHAVIOUR AND ADVERSE PREGNANCY OUTCOMES AMONG PREGNANT WOMEN IN A SECONDARY-LEVEL
Official scientific title EFFECTS OF A HEALTH EDUCATIONAL INTERVENTION ON MALARIA PREVENTIVE BEHAVIOUR AND ADVERSE PREGNANCY OUTCOMES AMONG PREGNANT WOMEN IN A SECONDARY-LEVEL HEALTH CENTRE IN MAIDUGURI, BORNO STATE, NIGERIA
Brief summary describing the background and objectives of the trial Malaria in pregnancy remains a serious public health problem in sub-Saharan Africa. It is also associated with serious consequences which include maternal and neonatal mortality; maternal anaemia; abortion; low birth weight, and others. The World Health Organisation (WHO) recommends for pregnant women in these endemic areas, the use of Insecticide Treated Nets (ITN) and Intermittent Preventive Treatment with Sulphadoxime-Pyrimethamine (IPT-SP). Despite the high prevalence of malaria among pregnant women in Maiduguri and its serious consequences, most of them do not adhere to these prescribed measures. The aim of this study is to develop, implement and assess the effects of a health education on these malaria preventive behaviours and adverse pregnancy outcomes among pregnant women in Maiduguri.
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 Education /Training
Anticipated trial start date 26/10/2016
Actual trial start date 26/10/2016
Anticipated date of last follow up 14/06/2017
Actual Last follow-up date 14/06/2017
Anticipated target sample size (number of participants) 352
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
nil known FPSK(FR16)P010
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 randomisation. Block sizes would be equal (4 each containing 2 intervention and 2 controls) Different persons would generate the sequnce from the person to allocate the sequence. It would be handed to the person allocating in sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education on malaria in pregnancy based on the IMB model one session 4 hours health education 176
Control Group Health education on breast feeding single session 4 hours Health education 176 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
First antenatal care visit. Nigerian. Resident in Maiduguri. Hypertension pre-eclampsia or eclampsia Diabetes mellitus Prior history of per vaginal bleeding in current pregnancy Pregnancy above 5 months Multiple pregnancy 18 Year(s) 45 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 30/09/2016 Ethics Committee for Research Involving Human Subjects of the Universiti Putra Malaysia (UPM)
Ethics Committee Address
Street address City Postal code Country
SERDANG SELANGOR 43400 UPM Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome information scores for malaria, motivation scores, malaria preventive behaviour skills scores, malaria preventive behaviour baseline 2-months post intervention 4-months post intervention
Secondary Outcome gestational age at delivery, Proportion of maternal anaemia, birth weight after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
State Specialist Hospital Maiduguri Shehu Laminu way Maiduguri PMB 1014 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
AHMED DAHIRU BALAMI 10B-1 Jalan 18/35 Sri Serdang Selangor 4330 Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AHMED DAHIRU BALAMI Jalan Kajang SELANGOR 43400 Malaysia University
COLLABORATORS
Name Street address City Postal code Country
SALMIAH MD SAID UPM SELANGOR 43400 Malaysia
NOR AFIAH ZULKEFLI UPM SELANGOR 43400 Malaysia
NORSA¿ADAH BACHOK USM KELANTAN Malaysia
BALA AUDU UMTH MAIDUGURI Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SALMIAH SAID salmiahms@upm.edu.my +60136362574 UPM SERDANG
City Postal code Country Position/Affiliation
SELANGOR 43400 Malaysia SENIOR MEDICAL LECTURER
Role Name Email Phone Street address
Public Enquiries SALMIAH SAID salmiahms@upm.edu.my +60136362574 UPM SERDANG
City Postal code Country Position/Affiliation
SELANGOR 43400 Malaysia SENIOR MEDICAL LECTURER
Role Name Email Phone Street address
Scientific Enquiries SALMIAH SAID salmiahms@upm.edu.my +60136362574 UPM SERDANG
City Postal code Country Position/Affiliation
SELANGOR 43400 Malaysia SENIOR MEDICAL LECTURER
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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