Professional Breastfeeding Support Intervention

NCT ID: NCT01893736

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 722 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-03-31

Brief Summary

The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.

Detailed Description

The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.

The primary hypotheses are:

1. 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);

2. 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:

1. 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;

2. 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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

In-hospital professional support

Intervention Type: OTHER

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.

Postpartum telephone follow-up support

Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.

Group Type: EXPERIMENTAL

Postpartum telephone follow-up support

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. delivers at participating trial site,

2. primiparous,

3. intends to breastfeed,

4. 18 years of age or older,

5. has singleton pregnancy,

6. Cantonese speaking,

7. Hong Kong resident for more than one year,

8. no serious medical or obstetrical complications

Exclusion Criteria

1. < 37 weeks gestation,

2. an Apgar score < 8 at five minutes,

3. a birth weight < 2500 grams,

4. born with any severe medical conditions or congenital malformations,

5. is placed in the special care nursery for more than 48 hours after delivery,

6. is placed in the intensive care nursery after delivery,

7. not entitled to health benefits in Hong Kong (NEP).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Marie Tarrant

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Tarrant, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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

Countries

Hong Kong

References

Fu IC, Fong DY, Heys M, Lee IL, Sham A, Tarrant M. Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. BJOG. 2014 Dec;121(13):1673-83. doi: 10.1111/1471-0528.12884. Epub 2014 May 26.

Reference Type: RESULT

PMID: 24861802 (View on PubMed)

Other Identifiers

PBFS-1

Identifier Type: -

Identifier Source: org_study_id