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

• Conditions: Breast Milk Collection; Breastfeeding; Breastfeeding, Exclusive
• Interventions: Behavioral: Antenatal hand expression

• Registration Number: NCT05066438
• Lead Sponsor: University of Saskatchewan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Study Start: 2021-11
• Primary Completion: 2022-08
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 176

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antenatal hand expression - intention to exclusively breastfeed	Antenatal hand expression	Eligible participants in this group intend to exclusively breastfeed AND must have received standardized counselling on and practiced antenatal hand expression for a minimum of 10 days beginning no earlier than 36 weeks gestational age.

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding to two months	This metric measured by questionnaire at two months	Participant-reported data on newborn dietary intake, collected by telephone questionnaire