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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04524286
Other study ID # 19/20/IRAS/CC
Secondary ID 26236945534
Status Completed
Phase
First received
Last updated
Start date November 6, 2020
Est. completion date March 31, 2022

Study information

Verified date April 2022
Source Bournemouth University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Interviews only.
Interviews will be conducted with childbearing women and midwives.

Locations

Country Name City State
United Kingdom Princess Anne Hospital - University Hospital Southampton Southampton

Sponsors (2)

Lead Sponsor Collaborator
Bournemouth University University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Interview with midwives Midwives willing to participate and share their experiences of providing care to women in the case setting. 12 months
Primary 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 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. 12 months
Secondary Memo writing Memos will be written throughout data collection and incorporated into data analysis. 12 months
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