IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Professional Breastfeeding Support Intervention
This study has been completed.
Sponsor:
The University of Hong Kong
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01893736
First received: June 6, 2013
Last updated: March 12, 2015
Last verified: March 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
| Condition | Intervention |
|---|---|
| Breastfeeding | Other: In-hospital professional support Other: Postpartum telephone follow-up support |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding |
Resource links provided by NLM:
Further study details as provided by Marie Tarrant, The University of Hong Kong:
Primary Outcome Measures:
- Prevalence of any and exclusive breastfeeding [ Time Frame: 1 month postpartum ]Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
- Prevalence of any and exclusive breastfeeding [ Time Frame: 2 months postpartum ]Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
- Prevalence of any and exclusive breastfeeding [ Time Frame: 3 months postpartum ]Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
Secondary Outcome Measures:
- Median duration of breastfeeding [ Time Frame: 6 month postpartum ]The median duration of any breastfeeding and the median duration of exclusive breastfeeding.
| Enrollment: | 722 |
| Study Start Date: | September 2010 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.
|
|
|
Experimental: In-hospital professional support
The participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization.
|
Other: In-hospital professional support
In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
|
|
Experimental: Postpartum telephone follow-up support
Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.
|
Other: Postpartum telephone follow-up support
Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.
|
Detailed Description:
The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.
The primary hypotheses are:
- Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
- The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
The secondary hypotheses are:
- The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
- The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- delivers at participating trial site,
- primiparous,
- intends to breastfeed,
- 18 years of age or older,
- has singleton pregnancy,
- Cantonese speaking,
- Hong Kong resident for more than one year,
- no serious medical or obstetrical complications
Exclusion Criteria:
- < 37 weeks gestation,
- an Apgar score < 8 at five minutes,
- a birth weight < 2500 grams,
- born with any severe medical conditions or congenital malformations,
- is placed in the special care nursery for more than 48 hours after delivery,
- is placed in the intensive care nursery after delivery,
- not entitled to health benefits in Hong Kong (NEP).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893736
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893736
Locations
| Hong Kong | |
| Kwong Wah Hospital | |
| Hong Kong, Hong Kong | |
| Pamela Youde Nethersole Eastern Hospital | |
| Hong Kong, Hong Kong | |
| Princess Margaret Hospital | |
| Hong Kong, Hong Kong | |
| Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
Sponsors and Collaborators
The University of Hong Kong
Investigators
| Principal Investigator: | Marie Tarrant, PhD, MPH, RN | The University of Hong Kong |
More Information
Publications:
| Responsible Party: | Marie Tarrant, Associate Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01893736 History of Changes |
| Other Study ID Numbers: |
PBFS-1 |
| Study First Received: | June 6, 2013 |
| Last Updated: | March 12, 2015 |
Keywords provided by Marie Tarrant, The University of Hong Kong:
|
Breastfeeding professional support postnatal |
interventions exclusive breastfeeding randomized controlled trial |
ClinicalTrials.gov processed this record on July 19, 2017