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.: PACTR201502000948394 Date of Approval: 27/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of the training of health care providers on the duration of exclusive breastfeeding
Official scientific title Effect of the Baby Friendly Hospital Initiative training on the duration of exclusive breastfeeding in Kinshasa: A cluster randomized trial
Brief summary describing the background and objectives of the trial Breastfeeding has many benefits for infants, mothers and families. It ensures child¿s growth, protects against common acute childhood infections, decreases the rate of Sudden Infant Death Syndrome, promotes cognitive development and, prevents atopic diseases, obesity and diabetes mellitus. For the mother, breastfeeding is economic, ensures maternal-child bonding, postpartum weight loss and birth spacing. Furthermore, breastfeeding protects against breast and ovarian cancers. The WHO and UNICEF recommend exclusive breastfeeding for six month. Despite this recommendation, rates of children breastfed exclusively up to six months remain low worldwide. The lack of breastfeeding support received by mothers from heath care providers is an important contributory factor of early cessation of exclusive breastfeeding. This study aimed to evaluate the effect of the training of health care providers in Baby friendly Hospital Initiative on the duration of exclusive breastfeeding in Kinshasa. Mothers were randomly allocated to one of the two groups. In the intervention group, mothers benefited of breastfeeding counseling supposed improved by the training of health care providers on the Baby Friendly Hospital Initiative. Indeed, we assumed that, due to the training of health care providers, breastfeeding counseling might be improved and might result in the reduction of the risk of discontinuing breastfeeding before six months. In the control group, mothers continued to receive routine breastfeeding counseling provided by non-retrained health workers. Mothers were recruited during antenatal care visits two weeks after the end of the training of health care providers, and followed up to six month after the childbirth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Exclusive breastfeeding,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 25/06/2012
Actual trial start date 16/07/2012
Anticipated date of last follow up 30/06/2013
Actual Last follow-up date 21/08/2013
Anticipated target sample size (number of participants) 368
Actual target sample size (number of participants) 422
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised This study is a clusters randomized trial. Clusters were constituted by maternities located in Kinshasa. As the Kinshasa city has six health districts, two were randomly selected using a table of random numbers. The list of all maternities located in these two selected health districts and the monthly mean number of births occurred in each maternity were obtained from the National Reproductive Health Program. From this list, 12 eligible maternities were randomly selected using Research Randomizer. To be eligible for the study, at least 60 births should occur in the maternity per month. The principal investigator was aware of the allocation of maternities in the study groups 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 WHO/UNICEF 20-hours course for maternity staff Heath care providers were trained in the Baby Friendly Hospital Initiative using the "20-hours course for maternity staff". We assumed that this training will result in the improvement of the breastfeeding counseling provided to mothers during antenatal care visits and during the stay in the maternity. 217
Control Group Nothing was done In the control group, health care workers were not trained. Mothers continued to receive routine cares; no improvement was made in the breastfeeding counseling provided to mothers. 205
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Attending the antenatal care service for the first time 2.Being at least 18 years old 3.Consented to participate in the study 4.Plan to give birth in the maternity where she attended antenatal care visits, a single alive full-term child who was free of any serious health conditions that would require transfer to an intensive care unit 1. Maternity with Baby Friendly Hospital label 2. Mothers unable to breastfeed for any reason 18 Year(s) 59 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 13/01/2012 The ethics committee of the Kinshasa School of Public Health
Ethics Committee Address
Street address City Postal code Country
University of Kinshasa Kinshasa 11850 Zaire
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cessation of exclusive breastfeeding First week after discharge from the maternity One month Two months Three months Four months Five months Six months
Secondary Outcome Improvement of the mother's breastfeeding self-efficacy and intention to breastfeed exclusively First week after discharge from the maternity
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CS BONDEKO ZS Kalamu 2 Kinshasa Zaire
CS St Armand Mombele Kinshasa Zaire
CHPK Bongolo Kinshasa Zaire
CME Ngaba Kianza Kinshasa Zaire
CS St Benoît Lemba Kinshasa Zaire
CS St Gabriel Lemba Super Kinshasa Zaire
CS Revolution Kisenso Kinshasa Zaire
CS St Ambroise Kisenso Gare Kinshasa Zaire
Hope Clinic Kingasani Pascal Kinshasa Zaire
CH Roi Baudouin Masina 1 Kinshasa Zaire
CH Kingasani Kingasani Kinshasa Zaire
FUNDING SOURCES
Name of source Street address City Postal code Country
Commission Universitaire pour le Développement¿ (CUD) Rue de Namur 72-74 Brussels 1000 Bruxelles Belgium
African Doctoral Dissertation Research Fellowship (ADDRF) APHRC Campus Manga Close off Kirawa Road Nairobi P.O BOX 10787-00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kinshasa School of Public Health University of Kinshasa Kinshasa 11850 Zaire University
Primary Sponsor Pélagie BABAKAZO Lumene 10 B , Quartier 4 , Ndjili Kinshasa Zaire University
Secondary Sponsor Kinshasa School of Public Health University of Kinshasa Kinshasa 11850 Zaire University
COLLABORATORS
Name Street address City Postal code Country
Emile Okitolonda University of Kinshasa Kinshasa Zaire
Philippe Donnen Brussels Belgium
Philippe Donnen Université Libre de Bruxelles Brussels Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pélagie Babakazo pbabakazo@yahoo.fr (+243) 999 992 286 Lumene 10B, Quartier 4, Ndjili
City Postal code Country Position/Affiliation
Kinshasa Zaire PhD student
Role Name Email Phone Street address
Public Enquiries Benjamin Bikunda babibikunda@yahoo.fr (+243) 998 242 476 University of Kinshasa
City Postal code Country Position/Affiliation
Kinshasa Zaire
Role Name Email Phone Street address
Scientific Enquiries Emile Okitolonda okitow@yahoo.fr (+243) 999 945 183 University of Kinshasa
City Postal code Country Position/Affiliation
Kinshasa Zaire Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information