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NCT05066438 Clinical Trial

The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months

Breastfeeding Clinical Trial

Official title:
The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05066438
Other study ID # Bio 2238
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2021
Est. completion date April 2023

Study information
Verified date October 2021
Source University of Saskatchewan
Contact Naida Hawkins, RN
Phone 3068437421
Email nhawkins@moremilksooner.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Despite recommendations by several health authorities, the rate of sustained exclusive breastfeeding for two months is less than fifty-five percent in Canada. The two most common reasons for early discontinuation are problems with milk supply and difficulty with technique. Antenatal hand expression (AHE) is a method used to assist with colostrum collection in low-risk pregnancies near term. This method has been shown to have several benefits, including increased milk supply at birth. This study aims to determine if the employment of antenatal hand expression in low-risk pregnancies near term affects the rate of sustained breastfeeding exclusively to two months.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 176
Est. completion date April 2023
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - inclusion to breastfeed - no contraindications to vaginal delivery - multiple gestation only if cleared for vaginal delivery Exclusion Criteria: - intention to formula feed - antenatal hand expression training provided by staff outside of study protocol - practiced antenatal hand expression prior to 36 weeks gestation - breech presentation - history of preterm labour, preterm birth or threatened preterm labour - history of (or current) cervical insufficiency - any contraindication to vaginal delivery (ie. placenta or vasa previa, classical uterine scar, etc.) - intrauterine growth restriction - antepartum hemorrhage - any contraindication to breastfeeding (eg. HIV) - multiple gestation requiring Cesarean delivery

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Antenatal hand expression
Standardized counselling and provision of information/resources on the practice of antenatal hand expression to encourage milk let down and colostrum production/collection.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Saskatchewan

Outcome
Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding to two months Participant-reported data on newborn dietary intake, collected by telephone questionnaire This metric measured by questionnaire at two months
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