BreastfeedingNCT05066438
The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
An observational study of Breastfeeding and Breastfeeding, Exclusive, run by University of Saskatchewan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive, Breast Milk Collection
- What is being tested?
- Antenatal hand expression
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- no contraindications to vaginal delivery
- multiple gestation only if cleared for vaginal delivery
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Antenatal hand expression
- Keywords
- antenatal, colostrum, hand expression, prenatal
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal hand expressionBehavioural
Standardized counselling and provision of information/resources on the practice of antenatal hand expression to encourage milk let down and colostrum production/collection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding to two months
Participant-reported data on newborn dietary intake, collected by telephone questionnaire
Measured: This metric measured by questionnaire at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almereau Prollius, University of Saskatchewan
- Investigators
- Almereau Prollius, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066438
- Sponsor's protocol ID
- Bio 2238
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prenatal Hand Expression on the Rate of Exclusive Breastfeeding to Two Months
- ClinicalTrials.gov ID
- NCT05066438
- Acronym / sponsor ID
- Bio 2238
- Keywords
- antenatal, colostrum, hand expression, prenatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal hand expression - intention to exclusively breastfeed | – | Behavioral: Antenatal hand expressionEligible 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- no contraindications to vaginal delivery
- multiple gestation only if cleared for vaginal delivery
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal hand expressionStandardized counselling and provision of information/resources on the practice of antenatal hand expression to encourage milk let down and colostrum production/collection. | Behavioural | Antenatal hand expression - intention to exclusively breastfeed |
Primary outcome
Exclusive breastfeeding to two months
Time frame: This metric measured by questionnaire at two months
Participant-reported data on newborn dietary intake, collected by telephone questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almereau Prollius, MD principal investigator
University of Saskatchewan
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Breastfeeding, Exclusive, run by University of Saskatchewan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naida Hawkins, RN (3068437421, nhawkins@moremilksooner.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding to two months (time frame: This metric measured by questionnaire at two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.