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.: PACTR202104543567379 Date of Approval: 20/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Preconception Care Counselling with Picture Based Education and Adherence to Iron Folic Acid Supplementation and its Outcome in Eastern Ethiopia
Official scientific title Neural Tube Defect: Determinants, Community experiences, Effect of Picture Based education on its birth outcome
Brief summary describing the background and objectives of the trial Antenatal care practice does not account for the importance of the preconception health of prospective parents and it should not be approached as an isolated activity rather with other strategies. To be mother in good health position another new protective strategy should be put in place. Preconception care is a promising new protective strategy to improve the health of maternal and fetal health through primary intervention. In Ethiopia, use of preconception care is low has although it offers many opportunities to deliver intentions for healthy pregnancy. This randomized control trial will evaluate the effect of picture based preconception counseling on adherence to Iron folic acid supplementation and birth outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 06/04/2021
Actual trial start date
Anticipated date of last follow up 06/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 244
Actual target sample size (number of participants) 244
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Preconception care counselling A daily dose (7 times a week) of ferrous sulfate + folic acid (50 mcg) For three months Intervention group will take a preconception iron folic acid supplement with a picture based preconception counseling 122
Control Group Iron folic acid supplement a daily dose (7 times a week) of ferrous sulfate + folic acid For three months Only iron folic acid supplement 122 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-A women between 18-45 years old who has an intention to have pregnancy (plans to have children), -Currently living in the study area (women who are usual residents and live or intend to live in the area for 6 or more months) and -Gives consent to participate. -Currently pregnant, a women that taking a long acting family planning after a women aborted spontaneously or gave birth a neonate who died after birth with neural tube defect and terminated due to neural tube defect, -Regularly consumed IFAS or micro mineral supplements in the past two months, -Non-Ethiopian subjects and participant who is mentally/physically challenged to provide consent will be excluded from the study. Adult: 19 Year-44 Year 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 26/08/2020 Jimma University Institution Review Board
Ethics Committee Address
Street address City Postal code Country
Jimma University main campus, street Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to iron folic acid supplementation After three months of starting treatment
Secondary Outcome Pregnancy and birth outcomes After six months starting from base line data is collected and during delivey
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gende kore health center Gende kore, 04 kebele Dire Dawa Ethiopia
Goro health center Goro, 02 kebele Dire Dawa Ethiopia
Addis Ketema Health center Addis ketema, 05 kebele Dire Dawa Ethiopia
Legehare health Center Legehare 08 kebele Dire Dawa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dire Dawa University and Dire Dawa Health Bureau Dire Dawa, 02 kebele, Sabiyan Dire Dawa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dire Dawa University Dire Dawa Dire Dawa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Professor Tefera Belachew Jimma Jimma Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anteneh Berhane antishaction@gmail.com 251915194454 Sabiyan, 02 kebele
City Postal code Country Position/Affiliation
Dire Dawa Ethiopia Lecturer and Ph D. fellow in nutrition at Jimma University faculty of Public Health Department of Nutrition and Dietetics
Role Name Email Phone Street address
Scientific Enquiries Tefera Belachew teferabelachew2@gmail.com 251917804072 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Promoter
Role Name Email Phone Street address
Public Enquiries Ketema Ayele ketemaayele2001@gmail.com 251937282987 Sabiyan, 02 kebele
City Postal code Country Position/Affiliation
Dire Dawa Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The finding of this intervention will be analyzed and disseminated through journal articles, policy reports, and presentations at national, regional, and international conferences and meetings. Study Protocol The primary outcome result will be shared with in four up to five months. Different peer reviewed journals
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