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Sexual and Gender MinoritiesNCT05354284

Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum

An observational study of Sexual and Gender Minorities and Pregnancy Complications, run by Linkoeping University at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
online questionnaire
How many people
200 participants
Where
1 siteSweden
Study dates
1 Oct 2021to Dec 2026
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Pregnant LBTQ people

Who may be able to join

  • Self defined LBTQ persons

Who cannot join

  • age under 18, not able to read Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Linköping University

    Linköping

Other trials in Sweden

About this study

Official title: Physical and Mental Health Among Sexual and Gender Minorities During

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:

Read more

PART I 2017 - 2021Pilotstudy

  1. To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
  2. To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
  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. 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. 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.
Read the detailed description

Mental illness (fear of childbirth included) during pregnancy increases the risk of adverse birth outcomes (e.g. preterm birth, low birth weight), obstetric complications (e.g. emergency caesarean, instrumental birth, major haemorrhage, perineal laceration), postpartum depression, and postpartum PTSD. Further, social vulnerability, such as belonging to an ethnic minority group, has also been shown to increase the risk of these birth-related complications.

It is also well known that sexual and gender minority (SGM) people (e.g. lesbian and bisexual women, transgender and genderqueer people) on average experience increased mental illness. This is thought to be the consequences of exposure to minority stress.

When stressors related to pregnancy and birth are added to the prolonged minority stress, mental illness increases as a consequence. Previous research shows increased depression, anxiety, and feelings of loneliness and dysphoria during pregnancy, as well as increased risk of postpartum depression, in SGM people.

This indicates that SGM people are at increased risk of adverse birth outcomes, obstetric complications, and traumatic birth experiences, followed by an increased risk of long-term negative effects on their mental and reproductive health. There is very little research on these issues. An American study found that incidence of preterm birth, low birth weight, stillbirth, and caesarean are increased among sexual minority women. However, there are no studies on birth outcomes in gender minority people. Nor are there any publications on obstetric complications or birth trauma in gender or sexual minority people. The present project fills these research gaps.

The data of a pilot study in pregnant SGM people shows an increased prevalence in this group. Fear of childbirth increases the risk of obstetric complications, and is a common reason for requested caesarean. There is unpublished clinical data on caesarean in SGM people that shows a huge overrepresentation in this group. Thus, the study preliminary data indicates that SGM people are at risk of adverse birth outcomes, obstetric complications, and birth trauma, and highlights the need for researching these issues thoroughly.

The overall purpose of the project is to increase knowledge about physical and mental health during pregnancy and postpartum in SGM people, as this knowledge is fundamental for improving the reproductive health of this group. The project has the following aims:

PART I 2017 - 2021Pilot study - data collection completed

  1. To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC
  2. To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study
  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. A register study.
  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. A longitudinal online survey.
  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. A qualitative study

The project will be conducted over three years as a collaboration between researchers at two departments at Linköping University: the Department of Biomedicine and Clinical sciences and the Department of Behavioural Sciences and Learning.

Study 1 is a retrospective register study, where data will be analysed during the first two years. Study 2 is a survey study with two measurements within approximately 6 months. It is important that the survey is launched shortly after the onset of the project, to ensure that a sufficient number of participants are included during the project time. Data from Study 2 will be analysed in the last two years of the project. Interviews for Study 3 will be conducted during the first project year and analysed in the second and third year.

This project will generate a knowledge contribution important for the improvement of reproductive health and rights of SGM people giving birth. The present lack of sufficient knowledge in this area is a barrier for healthcare in developing improved and competent care, and in reducing disparities for pregnant and birth-giving SGM people.

The findings of this project will be useful for healthcare professionals within the fields of reproductive and mental health, and will guide the development of accurate and adequate medical and nursing interventions directed at SGM people. Such interventions can be expected to decrease the incidence of adverse birth outcomes, obstetric complications, and birth trauma, improve care when they do occur, and lower the long-term negative health consequences of such sufferings. The project is important for promoting optimal medical and psychosocial outcomes for pregnant SGM people and their children.

Being tested
online questionnaire
Keywords
Obstetrical complications, Traumatic birth, Mental and physical health, Pregnancy, Birth, Postpartum
Medical subject headings
Coitus, Pregnancy Complications, Psychological Trauma, Birth Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • online questionnaireOther

    Questionnaire at three timepoints

Study groups in NCT05354284
Study groupRoleWhat they receive
Sexual gender minority peoplePeople 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.
Receives: Other: online questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BIrth experience

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

    Measured: 3 moths postpartum

  2. Obstetrical complications

    Self report questionnaire

    Measured: 3 moths postpartum

  3. Mental illness

    Qualitative interviews

    Measured: 3 moths postpartum

  4. Obstetrical complications

    Qualitative interviews

    Measured: 3 months postpartum

  5. Fear of child birth

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

    Measured: At inclusion

Secondary outcomes (5)
  1. Depression

    Hospital anxiety and depression Scale ( 0- 21 points per sub scale, high levels worse condition)

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

  2. Anxiety

    Hospital Anxiety and Depression Scale (0-21/ sub scale, higher levels worse condition.

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

  3. Traumatic Birth

    City Birth Trauma Scale (0-60 p, high levels means worse condition)

    Measured: 3 moths after birth

  4. Life quality

    Short Form Health Survey 36, SF 36 ( 0-100 high levels better quality of life/ sub scale)

    Measured: At inclusion and 1 year after birth

  5. Posttraumatic stress

    Impact of event scale 6 items (0-24, high levels more severe condition)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2022
  2. Study start1 Oct 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354284
Sponsor's protocol ID
Reg.nr 2017-499-31
Status last verified
Apr 2022
First submitted
2 Feb 2022
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sexual and Gender Minorities and Pregnancy Complications, run by Linkoeping University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BIrth experience (time frame: 3 moths postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

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