NCT05354284

Brief Summary

Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people. The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims: PART I 2017 - 2021Pilotstudy

  1. 1.To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
  2. 2.To investigate reasons to and consequences of FOC in SGM people
  3. 3.To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma.
  4. 4.To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects.
  5. 5.To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2021Dec 2026

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

5.2 years

First QC Date

February 2, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

Obstetrical complicationsTraumatic birthMental and physical healthPregnancyBirthPostpartum

Outcome Measures

Primary Outcomes (5)

  • BIrth experience

    Childbirth Experience Questionnaire (1-4 high levels more positive rating)

    3 moths postpartum

  • Obstetrical complications

    Self report questionnaire

    3 moths postpartum

  • Mental illness

    Qualitative interviews

    3 moths postpartum

  • Obstetrical complications

    Qualitative interviews

    3 months postpartum

  • Fear of child birth

    Wijma Delivery expectancy / experience questionnaire (min 0-max 165. the higher the more severe fear of childbirth)

    At inclusion

Secondary Outcomes (5)

  • Depression

    At inclusion, 3 months after birth and 1 year after birth

  • Anxiety

    At inclusion, 3 moths after birth and 1 year after birth

  • Traumatic Birth

    3 moths after birth

  • Life quality

    At inclusion and 1 year after birth

  • Posttraumatic stress

    At inclusion, 3 moths after birth and 1 year after birth

Study Arms (1)

Sexual gender minority people

People self defining Lesbian, Bi-sexual, Transgender, Quer or other are recruited and asked to fill in a questionnaire during pregnancy, three months postpartum and one year later.

Other: online questionnaire

Interventions

Questionnaire at three timepoints

Sexual gender minority people

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant LBTQ people

You may qualify if:

  • Self defined LBTQ persons

You may not qualify if:

  • age under 18, not able to read Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Sweden

Location

MeSH Terms

Conditions

CoitusPregnancy ComplicationsPsychological TraumaBirth Injuries

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

April 29, 2022

Study Start

October 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations