Early and Regular Breast Milk Expression to Help Establish Lactation After Delivery: a Randomized Controlled Trial - Full Text View

Sponsors and Collaborators:	National University Hospital, Singapore The University of Western Australia
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00393640

Purpose

The purpose of this study is to determine whether early start of either breastfeeding or breast milk expression may positively affect milk production later in lactation.

120 breastfeeding mothers will be recruited and randomized into 4 groups (2 groups with preterm deliveries) and 2 groups with term deliveries. One group will be given a breast pump to pump early and regularly. the second group will be encouraged to breastfeed in response to baby's cues. Breast milk samples will be collected at the end of a week.

Condition	Intervention
Pregnancy Breastfeeding	Procedure: Early and regular breast milk expression

MedlinePlus related topics: Breast Feeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Early and Regular Breast Milk Expression to Help Establish Lactation After Delivery: a Randomized Controlled Trial

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:

Successful initiation of lactation as determined by lactogenesis II markers. [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]
Successful initiation of lactation as determined by maternal perception. [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Volume of colostrum and milk expressed, and fed to the neonate [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]
Weight change in baby 7 days after birth. Statistical considerations [ Time Frame: 7 days postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2005
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Breast pump given and used on regular intervals	Procedure: Early and regular breast milk expression Breast pump given to be used on regular intervals
B: No Intervention
c: Active Comparator Breast pump given to be used on regular interval	Procedure: Early and regular breast milk expression Breast pump given to be used on regular intervals
D: No Intervention

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Eligibility

Ages Eligible for Study:	up to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

60 women with preterm pregnancies who want to breastfeed their babies will be recruited and 60 women with term pregnancies who want to breastfeed their babies will be recruited and randomized.

Exclusion Criteria:

Those with maternal diabetes and hyperprolactinaemia, as well as fetal congenital anomalies and multiple pregnancies will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393640

Contacts

Contact: Yap S Chong, MRACOG,MMED	(65) 67724261	obgcys@nus.edu.sg
Contact: Doris Fok, B.A., IBCLC	(65) 67724671	dorisdeborah@yahoo.com

Locations

Singapore
National University Hospital	Recruiting
Singapore, Singapore, 119074
Contact: Yap S Chong, MRACOG, MMED (65)67724261 obgcys@nus.edu.sg
Contact: Mattar Citra, MBBS 91184294 montrealdr@hotmail.com
Sub-Investigator: Fok Doris, B.A.,IBCLC
Sub-Investigator: Mary Rauff, MBBS,MMED
Sub-Investigator: Yiong H Chan, PhD
Sub-Investigator: Mark D Cregan, PhD

Sponsors and Collaborators

National University Hospital, Singapore

The University of Western Australia

Investigators

Principal Investigator:

Yap S Chong, MRACOG, MMED

National University Hospital, O & G

More Information

Publications:

Cregan MD, De Mello TR, Kershaw D, McDougall K, Hartmann PE. Initiation of lactation in women after preterm delivery. Acta Obstet Gynecol Scand. 2002 Sep;81(9):870-7.

Responsible Party:	National University Hospital ( Professor Chong Yap Seng )
Study ID Numbers:	NHG RPR 04027
Study First Received:	October 27, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00393640
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:

Early Initiation of lactogenesis II

ClinicalTrials.gov processed this record on January 14, 2009