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

NCT05365828 | Active Not Recruiting

• 2 other identifiers: EDGE 124858IRAS 264198
• Study Type: observational
• Target: 945
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Pregnancy Related

Keywords

LGBTQIA+ Reproduction; Resilience; Vulnerability; Risk; Neonatal Health; Parent Health; Allostatic Load

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (2)

• Secondary Scientific Aim - Understanding additional stressors and resilience

  through study completion, up to 10 months

• Secondary Scientific Aim - Contextualising resilience and vulnerability

  through study completion, up to 10 months

Study Arms (1)

Gestational parents

The study is composed of a sample of LGBTQIA+ and cisgender, heterosexual parents who are receiving antenatal care at the participating hospitals.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant people of all genders are welcome to participate within the study as long as they are receiving antenatal care at a participating Hospital Trust.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Gestational parents receiving antenatal care in Greater London.

You may qualify if:

• 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

You may not qualify if:

• Any pregnant persons under the age of 18
• Pregnant individuals using sites locations for Urgent care, A\&E, non-antenatal services only

Sponsors & Collaborators

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

Study Sites (14)

King's College Hospital NHS Foundation Trust

Brixton, SW9 8RR, United Kingdom

Location

Kingston Hospital NHS Foundation Trust

Kingston upon Thames, KT2 7QB, United Kingdom

Location

Barts Health NHS Trust

London, E1 2EF, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

Whittington Health NHS Trust

London, NW1 0PE, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Lewisham and Greenwich NHS Trust

London, SE13 6LH, United Kingdom

Location

St George's University Hospitals NHS foundation Trust

London, SW17 0RE, United Kingdom

Location

University College London Hospital NHS Foundation Trust

London, W1T 7DN, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Epsom and St Helier University Hospitals NHS Trust

Sutton, United Kingdom

Location

West Hertfordshire Teaching Hospitals NHS Trust

Watford, WD18 0HB, United Kingdom

Location

University Hospitals Sussex NHS Foundation

Worthing, BN11 2DH, United Kingdom

Location

Study Officials

• David M Frost, PhD

  University College, London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 9, 2022
• Study Start: May 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

GB (14)