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Completed

NCT Number: NCT01893736

Professional Breastfeeding Support Intervention

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

In-hospital professional support

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

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.

Primary outcomes

  1. Prevalence of any and exclusive breastfeeding

    Time frame: 1 month postpartum

    Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum

  2. Prevalence of any and exclusive breastfeeding

    Time frame: 2 months postpartum

    Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum

  3. Prevalence of any and exclusive breastfeeding

    Time frame: 3 months postpartum

    Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum

Secondary outcomes

  1. Median duration of breastfeeding

    Time frame: 6 month postpartum

    The median duration of any breastfeeding and the median duration of exclusive breastfeeding.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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