Condition category
Pregnancy and Childbirth
Date applied
15/11/2010
Date assigned
23/03/2011
Last edited
22/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.newcastle.edu.au/

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

Publication citations

Additional files

Editorial Notes