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

NCT ID: NCT05066438

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 176 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Antenatal hand expression

Intervention Type: BEHAVIORAL

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

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Almereau Prollius

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Almereau Prollius, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Central Contacts

Naida Hawkins, RN

Role: CONTACT

nhawkins@moremilksooner.com

3068437421

Other Identifiers

Bio 2238

Identifier Type: -

Identifier Source: org_study_id