Role of Midwifery Continuity of Care in Reducing Health Inequalities (Mi-CARE)

April 21, 2022 updated by: Bournemouth University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Southampton, United Kingdom
        • Princess Anne Hospital - University Hospital Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria - Childbearing Women

  • 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.

Inclusion Criteria - Midwives

  • 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.

Exclusion Criteria - Childbearing women

  • 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;
  • Women who lack capacity to provide informed consent;
  • Women who decline to participate and decline to provide informed consent.

Exclusion criteria - Midwives

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Public - Childbearing Women
Childbearing women living in three deprived areas in a city in the South of England.
Other: Interviews only.
Interviews will be conducted with childbearing women and midwives.
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.
Other: Interviews only.
Interviews will be conducted with childbearing women and midwives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Interview with midwives
Time Frame: 12 months
Midwives willing to participate and share their experiences of providing care to women in the case setting.
12 months
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Document analysis
Time Frame: 12 months
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.
12 months
Memo writing
Time Frame: 12 months
Memos will be written throughout data collection and incorporated into data analysis.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bournemouth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Southampton NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charlotte Clayton, Bournemouth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19/20/IRAS/CC
  • 262369 (OTHER: IRAS)
  • 45534 (OTHER: CPMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After the study has ended and for 25 years after this.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Interviews only.

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Dietary Supplements

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