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

NCT05066438 | Unknown

• 1 other identifier: Bio 2238
• Study Type: observational
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breastfeeding; Breastfeeding, Exclusive; Breast Milk Collection

Keywords

antenatal; colostrum; hand expression; prenatal

Outcome Measures

Primary Outcomes (1)

• Exclusive breastfeeding to two months

  Participant-reported data on newborn dietary intake, collected by telephone questionnaire

  This metric measured by questionnaire at two months

Study Arms (2)

Antenatal hand expression - intention to exclusively breastfeed

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.

Behavioral: Antenatal hand expression

No antenatal hand expression - intention to exclusively breastfeed

Eligible participants in this group intend to exclusively breastfeed but have NOT received any standardized counselling on antenatal hand expression and have not practiced antenatal hand expression OR have practiced antenatal hand expression but for less than 10 days.

Interventions

Antenatal hand expression BEHAVIORAL

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

Antenatal hand expression - intention to exclusively breastfeed

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in Saskatoon, Saskatchewan who intend to breastfeed. Prospective participants will be invited to enrol in this study if they meet inclusion criteria.

You may qualify if:

• no contraindications to vaginal delivery
• multiple gestation only if cleared for vaginal delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Almereau Prollius, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naida Hawkins, RN

CONTACT

3068437421; nhawkins@moremilksooner.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 4, 2021
• Study Start: November 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share