Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT07207759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MultIple Long-term Conditions in Pregnancy and Experiences of Midwifery Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences of care', 'timeFrame': '2025-2027', 'description': 'Pregnant and postnatal women with two or more long-term health conditions experience of midwifery care, as part of multi-disciplinary maternity care'}], 'secondaryOutcomes': [{'measure': 'Experiences of providing care', 'timeFrame': '2025-2027', 'description': "Midwives' experience of providing care for pregnant, birthing, and postnatal women with MLTC"}, {'measure': 'Experiences of providing care', 'timeFrame': '2025-2027', 'description': 'Health professionals experience of providing care for pregnant, birthing, and postnatal women with MLTC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Long-term Conditions', 'Midwife', 'Midwifery', 'Models of care', 'Multi-disciplinary care', 'Continuity of care(r)', 'Healthcare use', 'Care experiences', 'Burden of treatment'], 'conditions': ['How Pregnant and Postnatal Women With Two or More Long-term Health Conditions Experience Midwifery Care as Part of Multi-disciplinary Maternity Care']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://arc-sl.nihr.ac.uk/research-and-implementation/our-research-areas/maternity-and-perinatal-mental-health/exploring-0', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nCo-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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInterviews\n\nWomen and birthing people\n\n* 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\n* Able to provide consent\n* Able to participate in English or through an interpreter\n* 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.\n\nCo-design meetings\n\n* 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\n* 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\n* Able to provide consent\n* Able to participate in English or through an interpreter\n* Age 18 or over\n* NHS maternity staff including midwives and healthcare professionals who provide care or manage services for women with two or more long-term health conditions\n* Members of the Patient and Public Involvement and Engagement Group and Project Advisory Group\n* Representatives from the study third sector partners (Maternal Mental Health Alliance, Action on Pre-eclampsia and Social Action for Health)\n* Representatives from other relevant third sector organisations\n* Health policy makers and commissioners\n\nExclusion Criteria:\n\nInterviews Women and birthing people\n\n* Women and birthing people without two or more pre-existing long-term health conditions\n* Those who are not pregnant or have not given birth in the last two years\n* Those who refuse or are unable to give consent\n* Age under 18\n* Age over 60\n\nMidwives 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\n\n* Those who refuse or are unable to give consent\n* Age under 18'}, 'identificationModule': {'nctId': 'NCT07207759', 'acronym': 'MILLENIA', 'briefTitle': 'MultIple Long-term Conditions in Pregnancy and Experiences of Midwifery Care', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'MILLENIA: MultIpLe Long-tErm Conditions in Pregnancy aNd Experiences of mIdwifery cAre', 'orgStudyIdInfo': {'id': '323932'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interview participants', 'description': '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.\n\nUp 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'}, {'label': 'Co-design workshop participants', 'description': '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'Newcastle-upon-Tyne Hospitals NHS Trust', 'class': 'OTHER'}, {'name': 'Lancashire Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'The Whittington Hospital NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}