Contact information
Type
Scientific
Primary contact
Mrs Podjanee Parkpoom
ORCID ID
Contact details
School of Nursing and Midwifery
Richardson Wing
Faculty of Health
The University of Newcastle
Newcastle
2308
Australia
c3097593@uon.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Midwifery antenatal breastfeeding education intervention for increasing the rate of breastfeeding postpartum at one month in Thailand
Acronym
Study hypothesis
A midwife provided antenatal breastfeeding educational programme will be effective in increasing the rate of breastfeeding at one month following birth.
Please note, as of 22/09/2011 various updates have been made to the trial record. These changes can be found under this date of update in the relevant fields below.
The original public title was 'Breastfeeding rate at one month postpartum in Thailand'.
Both start and end dates have been updated. The original start date was 02/01/2011 and the original end date was 31/07/2012.
Ethics approval
University of Newcastle Human Research Ethics Committee approved on 13/04/2011. Variation approved on 20/09/2011 (ref: EC00144)
Study design
Two group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy and breastfeeding
Intervention
1. 1.5 hours sessions of group-based breastfeeding education.
2. The sessions will be designed and conducted in line with midwifery philosophy, self-efficacy theory and adult learning principles.
3. Women will commence their first session of group-based education at approximately 28 - 32 weeks gestation.
4. Group-based education will be provided to participants and their partners every fortnight.
5. The control group will receive standard care from the midwives at antenatal clinics.
6. The standard care does not include group-based antenatal education.
Additional contact names and email addresses:
Associate Professor Ashley Kable: Ashley.Kable@newcastle.edu.au
Dr Virginia Skinner: Virginia.Skinner@newcastle.edu.au
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measure as of 22/09/2011:
The rate of exclusive breastfeeding and predominant breastfeeding at one month
Previous primary outcome measure:
The effectiveness of a midwifery antenatal breastfeeding intervention which can be used by other midwives in Thailand to increase breastfeeding rates. (Evaluation of Group-Based Breastfeeding Programme: The intervention group, including partners, will be invited to complete an evaluation tool and comment on the strengths and limitations of the programme.)
Secondary outcome measures
Current secondary outcome measures as of 22/09/2011:
1) Evaluation of the breastfeeding program
2) Initiation of breastfeeding
3) Self-efficacy
4) Perceive breastfeeding support
5) Breastfeeding intention
Previous secondary outcome measure:
The rate of breastfeeding at one month which will be affected by the antenatal breastfeeding programme. (Data from completed telephone interviews tool will be analysed based on intention to treat and treatment received.)
Overall trial start date
02/10/2011
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 22/09/2011:
1) All primiparous pregnant women aged greater than 13 years old
2) Gestational ages between 24 and 28 weeks
3) Ability to speak Thai language
4) Neither intellectually nor mentally impaired in ways that would preclude effective group interaction
5) No serious concurrent diseases in ways that would preclude effective group interaction
Previous inclusion criteria:
1. Low risk pregnant women aged greater than 13 years old
2. Gestational ages between 24 and 29 weeks
(Other points remained unchanged)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Updated 22/09/2011: 166 participants randomly allocated (83 per group) (At time of registration: 470 participants randomly allocated (235 per group))
Participant exclusion criteria
Current exclusion criteria as of 22/09/2011:
1) Threatened premature labour after 20 weeks
2) Serious medical and obstetrical complications, e.g. heart disease, eclampsia and cervical incompetence
3) Alcohol use
Previous exclusion criteria:
1. Moderate to high risk pregnant women
2. Threatened abortion before 20 weeks
3. Threatened premature labour after 20 weeks
4. Serious medical and obstetrical complications, e.g. heart disease, ecalmpsia and cervical incompetence
5. Hypertension
6. Illicit drug use or alcohol use
7. Multiple pregnancies
Recruitment start date
02/10/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Thailand
Trial participating centre
School of Nursing and Midwifery, Richardson Wing
Newcastle
2308
Australia
Sponsor information
Organisation
The University of Newcastle (Australia)
Sponsor details
University Drive
Callaghan
Newcastle
2308
Australia
Ashley.Kable@newcastle.edu.au
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The University of Newcastle (Australia) - Faculty of Health, School of Nursing and Midwifery
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary