CClinicalTrials.gg
Status unknownNCT05066438Updated Oct 4, 2021

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

An observational study in Breastfeeding, Breastfeeding, Exclusive and Breast Milk Collection, sponsored by University of Saskatchewan. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-04.

Sponsored by University of Saskatchewan · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
176
Sex
Female
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Study 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.

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Conditions studied

  • Breastfeeding
  • Breastfeeding, Exclusive
  • Breast Milk Collection

Keywords

  • antenatal
  • colostrum
  • hand expression
  • prenatal
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In context

Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
176 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralAntenatal 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.

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What researchers measure

Primary outcomes

  1. Exclusive breastfeeding to two months

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

    Time frame: This metric measured by questionnaire at two months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05066438
Lead sponsor
University of Saskatchewan
Responsible party
Almereau Prollius (Principal Investigator, University of Saskatchewan) — Principal investigator
First posted
Oct 4, 2021
Start date
Nov 2021 (estimated)
Primary completion
Aug 2022 (estimated)
Completion
Apr 2023 (estimated)
Last update
Oct 4, 2021

Study contacts

Naida Hawkins, RN
Contact
nhawkins@moremilksooner.com
3068437421
Almereau Prollius, MD
principal investigator · University of Saskatchewan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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