NCT07207759

Brief Summary

This is a qualitative study using in-depth semi-structured interviews. This study will explore pregnant women with two or more long-term health condition's (MLTC) experience of midwifery care and midwives and health professionals experience of providing midwifery care and multidisciplinary maternity care. This will be considered in relation to Treatment Burden and Minimally Disruptive Healthcare theories. This will be followed by co-design of guidance for midwifery care of pregnant women with MLTC. The aim is to develop a rich understanding of the topic and participant's lived experiences, to enable development of a resource which is meaningful to the key stakeholders. The study is part of a wider mixed methods study.

Trial Health

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Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Oct 2025

Status
not yet recruiting

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

Study Progress38%
Oct 2025Apr 2027

First Submitted

Initial submission to the registry

June 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

October 6, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

June 12, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Multiple Long-term ConditionsMidwifeMidwiferyModels of careMulti-disciplinary careContinuity of care(r)Healthcare useCare experiencesBurden of treatment

Outcome Measures

Primary Outcomes (1)

  • Experiences of care

    Pregnant and postnatal women with two or more long-term health conditions experience of midwifery care, as part of multi-disciplinary maternity care

    2025-2027

Secondary Outcomes (2)

  • Experiences of providing care

    2025-2027

  • Experiences of providing care

    2025-2027

Study Arms (2)

Interview participants

Up to 20 women or birthing people who are pregnant or have experienced pregnancy with two or more long-term health conditions in the last two years. Up to 20 midwives who provide care or manage services for women with two or more long-term health conditions or healthcare professionals who collaborate with midwives

Co-design workshop participants

Up to 40 co-design participants including women and birthing people with two or more long-term health conditions who are pregnant or postnatal or have given birth in the last 3 years; partners/supporters/significant others of women with two or more long-term health conditions who are pregnant or postnatal or have given birth in the last 3 years; National Health Service maternity staff including midwives and healthcare professionals who provide care or manage services for women with two or more long-term health conditions; members of the Patient and Public Involvement and Engagement Group and Project Advisory Group; representatives from the study third sector Patient and Public Involvement and Engagement partners (Maternal Mental Health Alliance, Action on Pre-eclampsia and Social Action for Health); representatives from other relevant third sector organisations; health policy makers and commissioners

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Interviews: Women and staff with a range of physical and mental health long term conditions. Midwives and maternity healthcare professionals who provide care for women with MLTC such as obstetricians, obstetric physicians, or those in medicine, perinatal mental health and primary care. Co-design meetings: Some participants will be purposefully sampled from those who participated in interviews. If the desired sample size is not met through those participating in interviews, a further purposive sample will be recruited through third sector and professional networks and direct approach of potential participants at each site.

You may qualify if:

  • Interviews
  • Women and birthing people
  • Women and birthing people with two or more pre-existing long-term health conditions (see appendix one) who are pregnant or postnatal or have given birth in the last 2 years
  • Able to provide consent
  • Able to participate in English or through an interpreter
  • Age 18 or over Midwives and maternity health care professionals NHS maternity staff including midwives and healthcare professionals who provide or manage care for women with two or more long-term health conditions e.g., obstetricians, obstetric physicians, medicine, perinatal mental health, and primary care.
  • Co-design meetings
  • Women and birthing people with two or more long-term health conditions who are pregnant or postnatal or have given birth in the last 3 years (to include those who have given birth in the last 2 years at the beginning of the study who participated in an interview
  • Partners/supporters/significant others of women with two or more long-term health conditions who are pregnant or postnatal or have given birth in the last 3 years
  • Able to provide consent
  • Able to participate in English or through an interpreter
  • Age 18 or over
  • NHS maternity staff including midwives and healthcare professionals who provide care or manage services for women with two or more long-term health conditions
  • Members of the Patient and Public Involvement and Engagement Group and Project Advisory Group
  • Representatives from the study third sector partners (Maternal Mental Health Alliance, Action on Pre-eclampsia and Social Action for Health)
  • +2 more criteria

You may not qualify if:

  • Interviews Women and birthing people
  • Women and birthing people without two or more pre-existing long-term health conditions
  • Those who are not pregnant or have not given birth in the last two years
  • Those who refuse or are unable to give consent
  • Age under 18
  • Age over 60
  • Midwives and maternity health care professionals NHS maternity staff including midwives and healthcare professionals who do not provide or manage care for women with two or more pre-existing long-term health conditions Co-design meetings
  • Those who refuse or are unable to give consent
  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Design

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

Study Record Dates

First Submitted

June 12, 2025

First Posted

October 6, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

October 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share