A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding

Pregnancy Clinical Trial

— ABFS  

Official title:

A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648114
• Other study ID #: ABFS-1
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: March 12, 2015
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.

Description:

The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: February 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. singleton pregnancy,

2. primiparous

3. 18 years of age or older,

4. at least 36 weeks of gestation,

5. Cantonese speaking,

6. Hong Kong resident,

7. no serious medical or obstetrical complications,

8. staying in Hong Kong for at least 6 months after delivery, and

9. intention to breastfeed.

Exclusion Criteria:

Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding
• Pregnancy

Intervention

Other:
• Antenatal Breastfeeding Intervention
The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tsan Yuk Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Wong KL, Fong DY, Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-8. doi: 10.1097/AOG.0000000000000481. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive Breastfeeding Rate	Exclusive breastfeeding rate at 6 weeks postpartum	6 weeks postpartum	No
Secondary	Median Duration of Breastfeeding	The median duration of exclusive breastfeeding and the median duration of any breastfeeding	6 months postpartum	No
Secondary	Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum	Rate of Exclusive Breastfeeding at 3 Months and 6 Months Postpartum	6 Months Postpartum	No