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

May 9, 2023 updated by: University College, London

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Brixton, United Kingdom, SW9 8RR
        • Recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
          • Alice-Amanda Hinton
      • Kingston Upon Thames, United Kingdom, KT2 7QB
        • Recruiting
        • Kingston Hospital Nhs Foundation Trust
        • Contact:
          • Tracey O'Brien
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Alison Perry
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust
        • Contact:
          • Michelle Anderson
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Laura McCabe
      • London, United Kingdom, E1 2EF
        • Recruiting
        • Barts Health Nhs Trust
        • Contact:
          • Tabitha Newman
      • London, United Kingdom, E9 6SR
        • Recruiting
        • Homerton University Hospital NHS Foundation Trust
        • Contact:
          • Rachel Frowd
      • London, United Kingdom, NW1 0PE
        • Recruiting
        • Whittington Health NHS Trust
        • Contact:
          • Chinwe Obiozo
      • London, United Kingdom, SE13 6LH
        • Recruiting
        • Lewisham and Greenwich NHS Trust
        • Contact:
          • Tanwa Ogbara
      • London, United Kingdom, W1T 7DN
        • Recruiting
        • University College London Hospital NHS Foundation Trust
        • Contact:
          • Melissa Whitten
      • London, United Kingdom, SW17 0RE
        • Recruiting
        • St George's University Hospitals NHS Foundation Trust
        • Contact:
          • Lola Oshodi
      • Sutton, United Kingdom
        • Recruiting
        • Epsom and St Helier University Hospitals NHS Trust
        • Contact:
          • Agnieszka Aldana
      • Watford, United Kingdom, WD18 0HB
        • Recruiting
        • West Hertfordshire Teaching Hospitals NHS Trust
        • Contact:
          • Shikha Kapur
      • Worthing, United Kingdom, BN11 2DH
        • Recruiting
        • University Hospitals Sussex NHS Foundation
        • Contact:
          • Emily Marler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Gestational parents receiving antenatal care in Greater London.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, up to 10 months
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).
through study completion, up to 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Scientific Aim - Understanding additional stressors and resilience
Time Frame: through study completion, up to 10 months
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 Scientific Aim - Contextualising resilience and vulnerability
Time Frame: through study completion, up to 10 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Study Chair: David M Frost, PhD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EDGE 124858
  • IRAS 264198 (Other Identifier: Health Research Authority (HRA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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