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NCT Number: NCT05365828

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital NHS Foundation Trust, Brixton, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • 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 Hospitals 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 Trust
  • West Hertfordshire Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 9, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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