Health Knowledge, Attitudes, PracticeMi-CARENCT04524286
Role of Midwifery Continuity of Care in Reducing Health Inequalities
An observational study of Health Knowledge, Attitudes, Practice and Social Determinants, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
The impact of living in a deprived area has far reaching consequences on maternal and infant health. Studies in England show women living in deprived areas have some of the poorest experiences of care, poor birth outcomes and are 50% more likely to die of pregnancy related complications than women in the least… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Social Determinants, Public Health
- What is being tested?
- Interviews only.
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2020to 31 Mar 2022
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: * Childbearing women - Women who receive their care from one of the MCC caseloading teams. In the context of this study the term 'childbearing woman' is defined as any woman of childbearing age over the age of 16 years who is currently pregnant or up to five years post childbirth; * Midwives - Midwives working in the study setting or have worked in one of the MCC caseloading teams. Also, midwives at the study site who have managerial and leadership oversight of the MCC teams.
Who may be able to join
- Women who are currently receiving maternity care from the MCC caseloading teams;
- Women who have previously received care from one of the caseloading teams;
- Women aged 16 and over;
- Women who can understand English and are able to independently provide their informed consent;
- Women at any point in their pregnancy or up to five years following the birth of their babies. This time frame is considered appropriate in order to capture women who are currently receiving maternity care and those who have received care locally in the last five years. This will aim to also capture women's experiences before referral to the caseloading teams changed;
- Women who had or are currently having their maternity care provided by UHS.
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- Midwives who work in the MCC caseloading teams in the study setting;
- Midwives who have previously worked in the local MCC caseloading teams.
- Midwifery managers who have managerial oversight of the MCC caseloading teams.
Who cannot join
- Women who have not received care from one of the MCC caseloading teams;
- Women who gave birth more than five years ago;
- Women below the age of 16 years;
- Women who cannot speak English due to a lack of financial resources to fund translation services;
- Women who are in labour;
- Women who had their maternity care at a different NHS Trust;
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- Women who lack capacity to provide informed consent;
- Women who decline to participate and decline to provide informed consent.
- Midwives who work in the universal teams;
- MSWs due to different professional roles and responsibilities;
- Midwives who decline to participate and decline to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Princess Anne Hospital - University Hospital Southampton
Southampton
About this study
Official title: The Role of a Midwifery Continuity of CARE Model in Reducing Health Inequalities in Childbearing Women and Babies Living on a Low-income: The Mi-CARE Study
The impact of living in a deprived area has far reaching consequences on maternal and infant health. Studies in England show women living in deprived areas have some of the poorest experiences of care, poor birth outcomes and are 50% more likely to die of pregnancy related complications than women in the least deprived neighbourhoods. Life expectancy has also stalled for women living in the most deprived areas and the global COVID-19 pandemic has further amplified existing health inequalities.
The Social Determinants of Health (SDH) are the conditions in which people are born, grow, work, live, and age, and are mostly responsible for health inequities - the unfair and avoidable differences in health seen within and between populations. Evidence shows taking action on the SDH alongside Midwifery Continuity of Care (MCC) models, improves birth outcomes and reduces health inequalities. How midwives working in MCC models in areas of high deprivation address the SDH as part of their public health and prevention role is currently not clear. There is also a lack of qualitative evidence exploring the SDH from the perspectives of women themselves.
Drawing on Constructivist Grounded Theory methods, this research will take place in a low-income setting in England. Through the use of semi-structured interviews with women and midwives working in an NHS MCC model, the study will generate theory to help explain how and indeed whether midwives take action to address the SDH as part of their public health role. The study also seeks to understand the SDH impacting upon women's lives and what mechanisms exist to support or obstruct engagement with the SDH. Examining these domains will contribute to the evidence base about the impact of MCC and the public health and prevention strategy in NHS maternity services.
- Conditions
- Health Knowledge, Attitudes, Practice, Social Determinants, Public Health, Pregnancy Related
- Being tested
- Interviews only.
- Keywords
- Midwifery Continuity of Care, Social Determinants of Health, Childbearing women, Health inequalities/inequities, Constructivist Grounded Theory, Qualitative research
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews only.Other
Interviews will be conducted with childbearing women and midwives.
| Study group | Role | What they receive |
|---|---|---|
| Public - Childbearing Women | Childbearing women living in three deprived areas in a city in the South of England. Receives: Other: Interviews only. | |
| Staff - Midwives | Midwives working in caseloading teams providing continuity of care to women living in three deprived areas in a city in the South of England. Receives: Other: Interviews only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviews with childbearing women
Women living in the case setting willing to participate and share their maternity care experiences in one-to-one interviews.
Measured: 12 months
Interviews with childbearing women
Women living in the case setting willing to participate and share their childbearing experiences in one-to-one interviews.
Measured: 12 months
Interview with midwives
Midwives willing to participate and share their experiences of providing care to women in the case setting.
Measured: 12 months
Interview with midwives
Midwives willing to participate and share their knowledge about their public health role and how the actions they take to meet the needs of women.
Measured: 12 months
Secondary outcomes (2)
Document analysis
Analysis of documents such as policies, reports and guidelines which focus on maternal health inequalities, the public health role of midwives, and the role of midwifery-led continuity of care.
Measured: 12 months
Memo writing
Memos will be written throughout data collection and incorporated into data analysis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start6 Nov 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Charlotte Clayton, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524286
- Sponsor's protocol ID
- 19/20/IRAS/CC
- Other IDs
- 262369, 45534
- Acronym
- Mi-CARE
- Status last verified
- Apr 2022
- First submitted
- 14 Aug 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be anonymised, cleaned and stored within Bournemouth University's online research data repository BORDaR. This is a central location where research data generated by Bournemouth University is stored. This is accessible to the public for reuse.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Midwifery Continuity of CARE Model in Reducing Health Inequalities in Childbearing Women and Babies Living on a Low-income: The Mi-CARE Study
- ClinicalTrials.gov ID
- NCT04524286
- Acronym / sponsor ID
- Mi-CARE / 19/20/IRAS/CC
- Conditions
- Health Knowledge, Attitudes, Practice, Social Determinants, Public Health, Pregnancy Related
- Keywords
- Midwifery Continuity of Care, Social Determinants of Health, Childbearing women, Health inequalities/inequities, Constructivist Grounded Theory, Qualitative research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 Aug 2020 (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 impact of living in a deprived area has far reaching consequences on maternal and infant health. Studies in England show women living in deprived areas have some of the poorest experiences of care, poor birth outcomes and are 50% more likely to die of pregnancy related complications than women in the least deprived neighbourhoods. Life expectancy has also stalled for women living in the most deprived areas and the global COVID-19 pandemic has further amplified existing health inequalities.
The Social Determinants of Health (SDH) are the conditions in which people are born, grow, work, live, and age, and are mostly responsible for health inequities - the unfair and avoidable differences in health seen within and between populations. Evidence shows taking action on the SDH alongside Midwifery Continuity of Care (MCC) models, improves birth outcomes and reduces health inequalities. How midwives working in MCC models in areas of high deprivation address the SDH as part of their public health and prevention role is currently not clear. There is also a lack of qualitative evidence exploring the SDH from the perspectives of women themselves.
Drawing on Constructivist Grounded Theory methods, this research will take place in a low-income setting in England. Through the use of semi-structured interviews with women and midwives working in an NHS MCC model, the study will generate theory to help explain how and indeed whether midwives take action to address the SDH as part of their public health role. The study also seeks to understand the SDH impacting upon women's lives and what mechanisms exist to support or obstruct engagement with the SDH. Examining these domains will contribute to the evidence base about the impact of MCC and the public health and prevention strategy in NHS maternity services.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Public - Childbearing Women | – | Other: Interviews only.Childbearing women living in three deprived areas in a city in the South of England. |
| Staff - Midwives | – | Other: Interviews only.Midwives working in caseloading teams providing continuity of care to women living in three deprived areas in a city in the South of England. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- * Childbearing women - Women who receive their care from one of the MCC caseloading teams. In the context of this study the term 'childbearing woman' is defined as any woman of childbearing age over the age of 16 years who is currently pregnant or up to five years post childbirth; * Midwives - Midwives working in the study setting or have worked in one of the MCC caseloading teams. Also, midwives at the study site who have managerial and leadership oversight of the MCC teams.
Key inclusion criteria (9 listed)
- Women who are currently receiving maternity care from the MCC caseloading teams;
- Women who have previously received care from one of the caseloading teams;
- Women aged 16 and over;
- Women who can understand English and are able to independently provide their informed consent;
- Women at any point in their pregnancy or up to five years following the birth of their babies. This time frame is considered appropriate in order to capture women who are currently receiving maternity care and those who have received care locally in the last five years. This will aim to also capture women's experiences before referral to the caseloading teams changed;
Key exclusion criteria (11 listed)
- Women who have not received care from one of the MCC caseloading teams;
- Women who gave birth more than five years ago;
- Women below the age of 16 years;
- Women who cannot speak English due to a lack of financial resources to fund translation services;
- Women who are in 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 |
|---|---|---|
| Interviews only.Interviews will be conducted with childbearing women and midwives. | Other | Public - Childbearing Women, Staff - Midwives |
Primary outcome
Interviews with childbearing women
Time frame: 12 months
Women living in the case setting willing to participate and share their maternity care experiences in one-to-one interviews.
Interviews with childbearing women
Time frame: 12 months
Women living in the case setting willing to participate and share their childbearing experiences in one-to-one interviews.
Interview with midwives
Time frame: 12 months
Midwives willing to participate and share their experiences of providing care to women in the case setting.
Interview with midwives
Time frame: 12 months
Midwives willing to participate and share their knowledge about their public health role and how the actions they take to meet the needs of women.
2 secondary outcomes
Document analysis
Time frame: 12 months
Memo writing
Time frame: 12 months
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 22 Apr 2022.
- Individual participant dataSharing planned: Yes. The final dataset will be anonymised, cleaned and stored within Bournemouth University's online research data repository BORDaR. This is a central location where research data generated by Bournemouth University is stored. This is accessible to the public for reuse.
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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.
Charlotte Clayton principal investigator
Bournemouth University
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 Health Knowledge, Attitudes, Practice and Social Determinants, run by Bournemouth University 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 9 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: finished, as of the sponsor's last update on 22 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?
Interviews with childbearing women (time frame: 12 months). The study lists 4 primary outcomes in all. 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 22 Apr 2022.