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.: PACTR202205511366070 Date of Approval: 27/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of ‘Ready for Breastfeeding Programme’ as an Intervention Strategy to Strengthen Optimal Breastfeeding Support among Mothers in Ekiti State, Nigeria: A Randomized Control Trial
Official scientific title Effectiveness of ‘Ready for Breastfeeding Programme’ as an Intervention Strategy to Strengthen Optimal Breastfeeding Support among Mothers in Ekiti State, Nigeria: A Randomized Control Trial
Brief summary describing the background and objectives of the trial The RCT will involve pregnant women attending antenatal clinics at Ekiti State University Teaching Hospital, Ado-Ekiti (EKSUTH) and Federal Teaching Hospital, Ido-Ekiti (FETH) who will be randomly divided into two groups; intervention and control group. The pregnant women in the intervention group will be given "Ready for Breastfeeding Programme" which will be adapted from the World Health Organization (WHO)/United Nation International Children Emergency Fund (UNICEF) manual titled " WHO/UNICEF Protecting, Promoting and supporting breastfeeding in facilities providing maternity and newborn services". The women in the control group will be given the normal routine antenatal teaching. the groups will be observed for a period of six months postnatal to look out for the breastfeeding efficacy and the practice of exclusive breastfeeding.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Exclusive Breastfeeding
Purpose of the trial Education /Training
Anticipated trial start date 01/08/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 144
Actual target sample size (number of participants) 140
Recruitment status Closed to recruitment,follow-up continuing
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
Control Group Routine antenatal teaching Normal antenatal clinic days 30 minutes per clinic days 72 pregnant women randomly selected to the control group will be receiving the routine antenatal teaching on their normal antenatal clinic days 72 Active-Treatment of Control Group
Experimental Group Ready for Breastfeeding Programme Training of 90 minutes divided into 2; 45 minutes per session Two days training; 45 minutes per session Training on Ready for breastfeeding programme adapted from WHO/UNICEF manual on Protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services 72
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant women between the age of 18 years and above. • The age of pregnancy is between 30-36 weeks. • Singleton Pregnancy, considering exclusive breastfeeding. • Pregnant women planning to deliver baby in the same hospital where she had her ante natal clinics. • Pregnant women willing to stay in Ekiti for at least 6 months after delivery. • Pregnant women who have any medical complication during the pregnancy or delivery . Preterm delivery and neonate having any medical complication. Pregnant women planned for elective /emergency caesarean section 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 09/09/2021 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 1054 East London 5200 South Africa
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 26/08/2021 Human Research and Ethics Committee Federal Teaching Hospital Ido Ekiti
Ethics Committee Address
Street address City Postal code Country
PMB 201 Ido-Ekiti Ido-Ekiti 371101 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 30/08/2021 Ethics and Research Committee Ekiti State University Teaching Hospital Ado Ekiti
Ethics Committee Address
Street address City Postal code Country
Similoluwa Area Ado Ekiti Ado-Ekiti 360211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in the knowledge and attitude of the mother towards exclusive breastfeeding. Determined through a structured questionnaire. Immediately after delivery and 6 months post partum
Secondary Outcome The secondary outcome measures were assessed at baseline (during pregnancy), six weeks and six months. The secondary outcome measures include: • Practice of Exclusive breastfeeding with a validated structured questionnaire • Challenges of Exclusive breastfeeding with a validated structured questionnaire • Breastfeeding self-efficacy assessed with a Breastfeeding Efficacy short form (BFSE-F) Baseline, six weeks and six months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Antenatal clinic of Ekiti State University Teaching Hospital Ado Ekiti Sinmiloluwa Area, Ado-Ekiti AdoEkiti 360101 Nigeria
Antenatal clinic of Federal Teaching Hospital Ido Ekiti FETHI Ido Ekiti 371101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Rebecca Oluwaseun OKE Department of Nursing Science, Faculty of Basic Medical Sciences, College of Medicine, Ekiti State University, Ado-Ekiti Ado Ekiti 360211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Dr. Oke Olufemi Sunday Magodo Lagos 100001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Daniel Ter Goon PO Box 1054 East London 5200 South Africa
Dr. Nyani N. Nkutu PO Box 1054 East London 5200 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rebecca Oke rebeccoye@yahoo.com +2348032110925 Adebayo Area, Ado-Ekiti
City Postal code Country Position/Affiliation
Ado Ekiti 360101 Nigeria PhD Student
Role Name Email Phone Street address
Scientific Enquiries Daniel Goon dgoon@ufh.ac.za +27798572280 Church Street
City Postal code Country Position/Affiliation
East London 5200 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Nonyaniso Nkutu nnkutu@ufh.ac.za +27737420354 Church street
City Postal code Country Position/Affiliation
East London 5200 South Africa CoSupervisor
Role Name Email Phone Street address
Public Enquiries Olufemi Oke okemartins@gmail.com +2348060186795 Association of Reproductive and Family Health
City Postal code Country Position/Affiliation
Lagos 106104 Nigeria Director of Programs
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants were recruited after duly filled informed consent form. The data collected for the study will be made available through publication in learned journal immediately after completion of the trial. Informed Consent Form 4-6 months after trial Effectiveness of "Ready for breastfeeding program" as an intervention strategy to strengthen optimal breastfeeding support among mothers in Ekiti state, Nigeria
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