Feeding; Difficult, NewbornNCT05307497
An Exploration of Antenatal Hand Expression.
An observational study of Feeding; Difficult, Newborn, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Feeding; Difficult, Newborn
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2019to 28 Feb 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with experience of antenatal hand expression
Who may be able to join
- Women over the age of 18,
- Women with experience of antenatal hand expression within the last three months,
- Women with a good grasp of the English language.
Who cannot join
- Mothers of babies born before 37 weeks or with a medical issue (eg. tongue tie),
- Women with a mental health diagnosis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: An Exploration of Mother's Experiences of Antenatal Hand Expression of Colostrum, and the Effects Upon Breastfeeding Continuation and Maternal Emotional Health.
The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health
Read the detailed description
Second-line feeding strategies including hand expression and syringe feeding are used as an aid to breastfeeding, however little is known about their efficacy. This research explores the experiences of women who have used antenatal hand expression to identify how it affects maternal emotional health and breastfeeding continuation. UK women with recent experience of the practice were interviewed and the data analysed using thematic analysis. The results identified five themes in relation to these experiences including; The emotional distress of struggling with breastfeeding, Support as panacea but inconsistent, A crisis of confidence, Discord between knowledge, expectations and reality, and Syringe feeding as challenging but constructive. The study concludes that hand expression and syringe feeding supports women to establish breastfeeding, however, those struggling with breastfeeding need extra practical and emotional support to protect breastfeeding self-efficacy, emotional health and breastfeeding continuation. The findings highlight the importance of realistic, antenatal breastfeeding education to achieve this. Further research into second-line strategies and antenatal education programmes could contribute to the improvement of women's infant feeding experiences and improve UK breastfeeding rates.
- Conditions
- Feeding; Difficult, Newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview
Semi-structured interviews carried out with participants to collect qualitative data, analysed using thematic analysis.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start7 Feb 2019
- Primary completion20 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding; Difficult, NewbornStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307497
- Sponsor's protocol ID
- 249857
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of Mother's Experiences of Antenatal Hand Expression of Colostrum, and the Effects Upon Breastfeeding Continuation and Maternal Emotional Health.
- ClinicalTrials.gov ID
- NCT05307497
- Acronym / sponsor ID
- 249857
- Conditions
- Feeding; Difficult, Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 1 Apr 2022 (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.
The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health
Detailed description
Second-line feeding strategies including hand expression and syringe feeding are used as an aid to breastfeeding, however little is known about their efficacy. This research explores the experiences of women who have used antenatal hand expression to identify how it affects maternal emotional health and breastfeeding continuation. UK women with recent experience of the practice were interviewed and the data analysed using thematic analysis. The results identified five themes in relation to these experiences including; The emotional distress of struggling with breastfeeding, Support as panacea but inconsistent, A crisis of confidence, Discord between knowledge, expectations and reality, and Syringe feeding as challenging but constructive. The study concludes that hand expression and syringe feeding supports women to establish breastfeeding, however, those struggling with breastfeeding need extra practical and emotional support to protect breastfeeding self-efficacy, emotional health and breastfeeding continuation. The findings highlight the importance of realistic, antenatal breastfeeding education to achieve this. Further research into second-line strategies and antenatal education programmes could contribute to the improvement of women's infant feeding experiences and improve UK breastfeeding rates.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with experience of antenatal hand expression
Key inclusion criteria (3 listed)
- Women over the age of 18,
- Women with experience of antenatal hand expression within the last three months,
- Women with a good grasp of the English language.
Key exclusion criteria (2 listed)
- Mothers of babies born before 37 weeks or with a medical issue (eg. tongue tie),
- Women with a mental health diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semi-structured interview
Time frame: One hour
Semi-structured interviews carried out with participants to collect qualitative data, analysed using thematic analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding; Difficult, Newborn, run by University of Liverpool at 1 site in United Kingdom.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interview (time frame: One hour). 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 1 Apr 2022.