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

Sponsor
University of Saskatchewan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05066438
Collaborator
(none)
176
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Antenatal hand expression

Study Design

Study Type:
Observational
Anticipated Enrollment :
176 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Exclusive breastfeeding to two months [This metric measured by questionnaire at two months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Saskatchewan

Investigators

  • Principal Investigator: Almereau Prollius, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Almereau Prollius, Principal Investigator, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT05066438
Other Study ID Numbers:
  • Bio 2238
First Posted:
Oct 4, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Almereau Prollius, Principal Investigator, University of Saskatchewan

Study Results

No Results Posted as of Oct 4, 2021