Clinical trial NCT05365828: Legacies and Futures: Measuring Roles of Resilience and Vulnerability in Pregnancy and Birth Outcomes
Official title: Legacies and Futures: Gestational Parents' Experiences With Vulnerability and Resilience as it Influence Parent and Neonatal Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Related
Keywords: LGBTQIA+ Reproduction
Resilience
Vulnerability
Risk
Neonatal Health
Parent Health
Allostatic Load
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: UCL, Bloomsbury and East London (UBEL) Doctoral Training Partnership
name: Economic and Social Research Council, United Kingdom
name: University College London Hospitals
name: King's College Hospital NHS Trust
name: University Hospitals Sussex NHS Foundation
name: Homerton University Hospital
name: Barts & The London NHS Trust
name: The Whittington Hospital NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: West Hertfordshire Hospitals NHS Trust
name: Kingston Hospital NHS Trust
name: Royal Free Hospital NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: Epsom and St Helier University Hospitals NHS Trust
name: Lewisham and Greenwich NHS Trust
name: St George's University Hospital NHS Foundation Trust
First posted: 2022-05-09
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gestational parents receiving antenatal care in Greater London.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Scientific Aim - Parental Health
timeFrame: through study completion, up to 10 months
measure: Primary Scientific Aim - Infant Health
timeFrame: through study completion, up to 10 months
Secondary outcomes:
measure: Secondary Scientific Aim - Understanding additional stressors and resilience
timeFrame: through study completion, up to 10 months
measure: Secondary Scientific Aim - Contextualising resilience and vulnerability
timeFrame: through study completion, up to 10 months
Other outcomes:
Locations:
city: Brixton
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Kingston Upon Thames
country: United Kingdom
facility: Kingston Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Whittington Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Lewisham and Greenwich NHS Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS foundation Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Epsom and St Helier University Hospitals NHS Trust
city: Watford
country: United Kingdom
facility: West Hertfordshire Teaching Hospitals NHS Trust
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation
Study officials:
affiliation: University College, London
name: David M Frost, PhD
role: STUDY_CHAIR
References: