Early and Regular Breast Milk Expression to Help Establish Lactation After Delivery: a Randomized Controlled Trial
Pumping
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Feb 2005
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 27, 2006
CompletedFirst Posted
Study publicly available on registry
October 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 21, 2009
September 1, 2009
3.7 years
October 27, 2006
September 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Successful initiation of lactation as determined by lactogenesis II markers.
7 days postpartum
Successful initiation of lactation as determined by maternal perception.
7 days postpartum
Secondary Outcomes (2)
Volume of colostrum and milk expressed, and fed to the neonate
7 days postpartum
Weight change in baby 7 days after birth. Statistical considerations
7 days postpartum
Study Arms (4)
A
ACTIVE COMPARATORBreast pump given and used on regular intervals
B
NO INTERVENTIONc
ACTIVE COMPARATORBreast pump given to be used on regular interval
D
NO INTERVENTIONInterventions
Breast pump given to be used on regular intervals
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Those with maternal diabetes and hyperprolactinaemia, as well as fetal congenital anomalies and multiple pregnancies will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, 119074, Singapore
Related Publications (1)
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. doi: 10.1034/j.1600-0412.2002.810913.x.
PMID: 12225305BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yap S Chong, MRACOG, MMED
National University Hospital, O & G
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2006
First Posted
October 30, 2006
Study Start
February 1, 2005
Primary Completion
October 1, 2008
Study Completion
March 1, 2009
Last Updated
September 21, 2009
Record last verified: 2009-09