Legacies and Futures: Measuring Roles of Resilience and Vulnerability in Pregnancy and Birth Outcomes

Pregnancy Related Clinical Trial

Official title:

Legacies and Futures: Gestational Parents' Experiences With Vulnerability and Resilience as it Influence Parent and Neonatal Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365828
• Other study ID #: EDGE 124858
• Secondary ID: IRAS 264198
• Status: Recruiting
• Start date: May 17, 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: University College, London
• Contact: Study Coordinator
• Phone: +44 020 3108 4358
• Email: stnvkll[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any pregnant persons under the age of 18

• Pregnant individuals using sites locations for Urgent care, A&E, non-antenatal services only

Related Conditions & MeSH terms

• Pregnancy Related

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	Brixton
United Kingdom	Kingston Hospital NHS Foundation Trust	Kingston Upon Thames
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Homerton University Hospital NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Lewisham and Greenwich NHS Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	St George's University Hospitals NHS foundation Trust	London
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	Whittington Health NHS Trust	London
United Kingdom	Epsom and St Helier University Hospitals NHS Trust	Sutton
United Kingdom	West Hertfordshire Teaching Hospitals NHS Trust	Watford
United Kingdom	University Hospitals Sussex NHS Foundation	Worthing

Sponsors (17)

Lead Sponsor

Collaborator

University College, London

Barts & The London NHS Trust, Economic and Social Research Council, United Kingdom, Epsom and St Helier University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Homerton University Hospital, Imperial College Healthcare NHS Trust, King's College Hospital NHS Trust, Kingston Hospital NHS Trust, Lewisham and Greenwich NHS Trust, Royal Free Hospital NHS Foundation Trust, St George's University Hospital NHS Foundation Trust, The Whittington Hospital NHS Trust, UCL, Bloomsbury and East London (UBEL) Doctoral Training Partnership, University College London Hospitals, University Hospitals Sussex NHS Foundation, West Hertfordshire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	through study completion, up to 10 months
Primary	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).	through study completion, up to 10 months
Secondary	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.	through study completion, up to 10 months
Secondary	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.	through study completion, up to 10 months