NCT01893736CompletedNot Applicable
A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
The University of Hong Kong4 sites in 1 country722 target enrollmentStarted: September 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 722
- Locations
- 4
- Primary Endpoint
- Prevalence of any and exclusive breastfeeding
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
Prevalence of any and exclusive breastfeeding
Time Frame: 3 months postpartum
Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
Secondary Outcomes
- Median duration of breastfeeding(6 month postpartum)
Investigators
Marie Tarrant
Associate Professor
The University of Hong Kong
Study Sites (4)
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