Pregnancy RelatedNCT05365828
Legacies and Futures: Measuring Roles of Resilience and Vulnerability in Pregnancy and Birth Outcomes
An observational study of Pregnancy Related, run by University College, London at 14 sites in United Kingdom.
Trial summary
Pregnancy care typically assumes patients are heterosexual married women whose gender matches their assigned sex (i.e., cisgender), stigmatizing patients and creating limitations, blocking affirming care. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 945 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 17 May 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Gestational parents receiving antenatal care in Greater London.
Who may be able to join
- Legal adult of reproductive age (18-49)
- Identifies as a lesbian, gay, bisexual, queer, nonbinary, intersex, and/or transgender (or cisgender and heterosexual for comparison sample)
- Currently pregnant and receiving antenatal care at one of the study sites
Who cannot join
- Any pregnant persons under the age of 18
- Pregnant individuals using sites locations for Urgent care, A\&E, non-antenatal services only
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
King's College Hospital NHS Foundation Trust
Brixton, SW9 8RR
Kingston Hospital NHS Foundation Trust
Kingston upon Thames, KT2 7QB
Barts Health NHS Trust
London, E1 2EF
Homerton University Hospital NHS Foundation Trust
London, E9 6SR
Whittington Health NHS Trust
London, NW1 0PE
Royal Free London NHS Foundation Trust
London, NW3 2QG
Lewisham and Greenwich NHS Trust
London, SE13 6LH
St George's University Hospitals NHS foundation Trust
London, SW17 0RE
University College London Hospital NHS Foundation Trust
London, W1T 7DN
Imperial College Healthcare NHS Trust
London, W2 1NY
Guy's and St Thomas' NHS Foundation Trust
London
Epsom and St Helier University Hospitals NHS Trust
Sutton
West Hertfordshire Teaching Hospitals NHS Trust
Watford, WD18 0HB
University Hospitals Sussex NHS Foundation
Worthing, BN11 2DH
About this study
Official title: Legacies and Futures: Gestational Parents' Experiences With Vulnerability and Resilience as it Influence Parent and Neonatal Health
Pregnancy care typically assumes patients are heterosexual married women whose gender matches their assigned sex (i.e., cisgender), stigmatizing patients and creating limitations, blocking affirming care. Consequently, lesbian, gay, bisexual, queer, intersex, asexual, and/or transgender (LGBTQIA+) parents face minority stress as discrimination in antenatal care. This mixed-methods study assesses stressors and resilience factors on pregnancy and birth outcomes. LGBTQIA+ pregnant parents (n=200) are case-matched with cisheterosexual peers (n=600). Primary data comes from two panel surveys, one antenatally and one postpartum, combined with medical records. A sub-sample (n=30) will complete a journal between surveys. Findings will inform care guidelines and provider training.
Read the detailed description
Patients using reproductive health services, like care during pregnancy (called antenatal care), are most often assumed to be heterosexual married women whose gender matched their sex assigned at birth (i.e., cisgender). Due to these assumptions, pregnancy care procedures are based on a sweeping assumption of who becomes pregnant and gives birth. This assumption is based on the pregnant person's gender and/or sexual orientation. As a result of this assumption, parents who are lesbian, gay, bisexual, queer, intersex, asexual, non-binary, and/or transgender (LGBTQIA+) can experience stress in the form of stigma, prejudice, and discrimination (i.e. "minority stress"). In the United Kingdom, there are 525,000 LGBTQIA+ potential gestational patients who may face this type of stress while receiving pregnancy care. That means that there is a preventable higher risk for pregnancy and birth complications caused by increased stress during pregnancy and daily life. These complications include macrosomia, pre-term birth, and low-birth weight. Preventable stress, also called minority stress, links to this increase in health problems outside of pregnancy as well. Since minority stress influences patient/parents' health, it is also called a risk or vulnerability. Resilience, or the ability to overcome stress and discrimination, can sometimes help improve health outcomes. However, little is known about which types of resilience can be helpful for LGBTQIA+ parents given their unique experiences of minority stress.
The planned observational study will investigate the ways in which experiences of minority stress and resilience in pregnancy care are associated with parent health and birth outcomes. A sample of pregnant patients (N=800) from maternity wards in and around London will take part through an online panel survey (completed twice) that will be linked to each patient/participant's electronic health records to create a quantitative dataset. Participant recruitment will focus on LGBTQIA+ pregnant patients (n=200). A matched comparison sample of cisgender, heterosexual pregnant patients (n=600) will also be recruited to take part from the same maternity. From the full sample, patient/parents from University College London Hospital will be invited to complete an at-home journal activity which will provide qualitative data on their experiences of minority stress and resilience. This smaller group (n=30). Results from this study can be used to inform LGBTQIA+ guidelines, training, and help make reproductive healthcare more inclusive.
- Conditions
- Pregnancy Related
- Keywords
- LGBTQIA+ Reproduction, Resilience, Vulnerability, Risk, Neonatal Health, Parent Health, Allostatic Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gestational parents | The study is composed of a sample of LGBTQIA+ and cisgender, heterosexual parents who are receiving antenatal care at the participating hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Scientific Aim - Parental Health
The outcome measured for impact from resilience and vulnerability is parent health as allostatic load (as health data from routine antenatal check-ups). Scales will be composited into intrapersonal stressors (i.e., felt stigma, level of outness), interpersonal stressors (i.e., homelessness \& child welfare, stressful life events/stress, everyday discrimination, chronic strains, police interactions), structural stressors (i.e., household social vulnerability index, deprivation score), intrapersonal resilience (i.e., coping, social support), interpersonal resilience (i.e., patient experience scale, shared decision-making, emotional reactivity), and structural resilience (i.e., community connectedness, civic engagement).
Measured: through study completion, up to 10 months
Primary Scientific Aim - Infant Health
The composite for parent health (i.e. allostatic load from Outcome 1) will be assessed to see if there is an impact on infant health (a composite of head circumference, gestational length, birth weight, birth length, Apgar score).
Measured: through study completion, up to 10 months
Secondary outcomes (2)
Secondary Scientific Aim - Understanding additional stressors and resilience
Qualitative journals will be used to assess for additional stressors and resilience resources to ascertain if there are measures that have not been accounted for within the quantitative measures. These are presently unknown, as the point of the measure is to uncover these dimensions of the constructs of resilience and vulnerability.
Measured: through study completion, up to 10 months
Secondary Scientific Aim - Contextualising resilience and vulnerability
The same qualitative journals in outcome 3 will also provided narratives about the experiences of parents with extreme resilience and vulnerability scores. The assessment of these narratives will be done to help contextualise the presence of extreme scores for parents receiving antenatal care at UCLH. The contents of these narratives collectively will be reported within the final findings alongside the quantitative data, as well as will be quoted specifically when relevant.
Measured: through study completion, up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start17 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 945 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- UCL, Bloomsbury and East London (UBEL) Doctoral Training Partnership, Economic and Social Research Council, United Kingdom, University College London Hospitals, King's College Hospital NHS Trust, University Hospitals Sussex NHS Foundation Trust, Homerton University Hospital, Barts & The London NHS Trust, The Whittington Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust, Kingston Hospital NHS Trust, Royal Free Hospital NHS Foundation Trust, Imperial College Healthcare NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Lewisham and Greenwich NHS Trust, St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- David M Frost, PhD, Study chair, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365828
- Sponsor's protocol ID
- EDGE 124858
- Other IDs
- IRAS 264198
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Legacies and Futures: Gestational Parents' Experiences With Vulnerability and Resilience as it Influence Parent and Neonatal Health
- ClinicalTrials.gov ID
- NCT05365828
- Acronym / sponsor ID
- EDGE 124858
- Conditions
- Pregnancy Related
- Keywords
- LGBTQIA+ Reproduction, Resilience, Vulnerability, Risk, Neonatal Health, Parent Health, Allostatic Load
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 945 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- UCL, Bloomsbury and East London (UBEL) Doctoral Training Partnership, Economic and Social Research Council, United Kingdom, University College London Hospitals, King's College Hospital NHS Trust, University Hospitals Sussex NHS Foundation Trust, Homerton University Hospital, Barts & The London NHS Trust, The Whittington Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust, Kingston Hospital NHS Trust, Royal Free Hospital NHS Foundation Trust, Imperial College Healthcare NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Lewisham and Greenwich NHS Trust, St George's University Hospitals NHS Foundation Trust
- Study start
- 17 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy care typically assumes patients are heterosexual married women whose gender matches their assigned sex (i.e., cisgender), stigmatizing patients and creating limitations, blocking affirming care. Consequently, lesbian, gay, bisexual, queer, intersex, asexual, and/or transgender (LGBTQIA+) parents face minority stress as discrimination in antenatal care. This mixed-methods study assesses stressors and resilience factors on pregnancy and birth outcomes. LGBTQIA+ pregnant parents (n=200) are case-matched with cisheterosexual peers (n=600). Primary data comes from two panel surveys, one antenatally and one postpartum, combined with medical records. A sub-sample (n=30) will complete a journal between surveys. Findings will inform care guidelines and provider training.
Detailed description
Patients using reproductive health services, like care during pregnancy (called antenatal care), are most often assumed to be heterosexual married women whose gender matched their sex assigned at birth (i.e., cisgender). Due to these assumptions, pregnancy care procedures are based on a sweeping assumption of who becomes pregnant and gives birth. This assumption is based on the pregnant person's gender and/or sexual orientation. As a result of this assumption, parents who are lesbian, gay, bisexual, queer, intersex, asexual, non-binary, and/or transgender (LGBTQIA+) can experience stress in the form of stigma, prejudice, and discrimination (i.e. "minority stress"). In the United Kingdom, there are 525,000 LGBTQIA+ potential gestational patients who may face this type of stress while receiving pregnancy care. That means that there is a preventable higher risk for pregnancy and birth complications caused by increased stress during pregnancy and daily life. These complications include macrosomia, pre-term birth, and low-birth weight. Preventable stress, also called minority stress, links to this increase in health problems outside of pregnancy as well. Since minority stress influences patient/parents' health, it is also called a risk or vulnerability. Resilience, or the ability to overcome stress and discrimination, can sometimes help improve health outcomes. However, little is known about which types of resilience can be helpful for LGBTQIA+ parents given their unique experiences of minority stress.
The planned observational study will investigate the ways in which experiences of minority stress and resilience in pregnancy care are associated with parent health and birth outcomes. A sample of pregnant patients (N=800) from maternity wards in and around London will take part through an online panel survey (completed twice) that will be linked to each patient/participant's electronic health records to create a quantitative dataset. Participant recruitment will focus on LGBTQIA+ pregnant patients (n=200). A matched comparison sample of cisgender, heterosexual pregnant patients (n=600) will also be recruited to take part from the same maternity. From the full sample, patient/parents from University College London Hospital will be invited to complete an at-home journal activity which will provide qualitative data on their experiences of minority stress and resilience. This smaller group (n=30). Results from this study can be used to inform LGBTQIA+ guidelines, training, and help make reproductive healthcare more inclusive.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational parents | – | –The study is composed of a sample of LGBTQIA+ and cisgender, heterosexual parents who are receiving antenatal care at the participating hospitals. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Gestational parents receiving antenatal care in Greater London.
Key inclusion criteria (3 listed)
- Legal adult of reproductive age (18-49)
- Identifies as a lesbian, gay, bisexual, queer, nonbinary, intersex, and/or transgender (or cisgender and heterosexual for comparison sample)
- Currently pregnant and receiving antenatal care at one of the study sites
Key exclusion criteria (2 listed)
- Any pregnant persons under the age of 18
- Pregnant individuals using sites locations for Urgent care, A\&E, non-antenatal services only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Scientific Aim - Parental Health
Time frame: through study completion, up to 10 months
The outcome measured for impact from resilience and vulnerability is parent health as allostatic load (as health data from routine antenatal check-ups). Scales will be composited into intrapersonal stressors (i.e., felt stigma, level of outness), interpersonal stressors (i.e., homelessness \& child welfare, stressful life events/stress, everyday discrimination, chronic strains, police interactions), structural stressors (i.e., household social vulnerability index, deprivation score), intrapersonal resilience (i.e., coping, social support), interpersonal resilience (i.e., patient experience scale, shared decision-making, emotional reactivity), and structural resilience (i.e., community connectedness, civic engagement).
Primary Scientific Aim - Infant Health
Time frame: through study completion, up to 10 months
The composite for parent health (i.e. allostatic load from Outcome 1) will be assessed to see if there is an impact on infant health (a composite of head circumference, gestational length, birth weight, birth length, Apgar score).
2 secondary outcomes
Secondary Scientific Aim - Understanding additional stressors and resilience
Time frame: through study completion, up to 10 months
Secondary Scientific Aim - Contextualising resilience and vulnerability
Time frame: through study completion, up to 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Frost, PhD study chair
University College, London
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by University College, London at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Scientific Aim - Parental Health (time frame: through study completion, up to 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.