NCT04524286

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

August 14, 2020

Last Update Submit

April 21, 2022

Conditions

Keywords

Midwifery Continuity of CareSocial Determinants of HealthChildbearing womenHealth inequalities/inequitiesConstructivist Grounded TheoryQualitative research

Outcome Measures

Primary Outcomes (4)

  • Interviews with childbearing women

    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

    Women living in the case setting willing to participate and share their childbearing experiences in one-to-one interviews.

    12 months

  • Interview with midwives

    Midwives willing to participate and share their experiences of providing care to women in the case setting.

    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.

    12 months

Secondary Outcomes (2)

  • Document analysis

    12 months

  • Memo writing

    12 months

Study Arms (2)

Public - Childbearing Women

Childbearing women living in three deprived areas in a city in the South of England.

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.

Other: Interviews only.

Interventions

Interviews will be conducted with childbearing women and midwives.

Public - Childbearing WomenStaff - Midwives

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Anne Hospital - University Hospital Southampton

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Charlotte Clayton

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 24, 2020

Study Start

November 6, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
After the study has ended and for 25 years after this.
More information

Locations