Inflammatory Bowel DiseasesNCT03725124
Family Planning in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study explores the lived experiences of family planning for women with inflammatory bowel disease (IBD) and their partners during the reproductive stages of pre-conception, pregnancy and the postnatal period through qualitative interviews. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Interview
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Women with inflammatory bowel disease (IBD), partners of women with IBD and healthcare professionals working with women with IBD will be recruited via patient groups and secondary care IBD clinics.
Who may be able to join
- Women diagnosed with IBD at different family planning stages (pre-pregnancy, pregnancy and post-partum).
- Women diagnosed with IBD's partners.
- Health practitioners involved with women diagnoses with IBD and on-going care (phase 3 only).
Who cannot join
- Does not consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
Official title: The Lived Experience of Family Planning of Female Patients Diagnosed With Inflammatory Bowel Disease (IBD) and Their Partners During Key Reproductive Stages - a Qualitative Study
This study explores the lived experiences of family planning for women with inflammatory bowel disease (IBD) and their partners during the reproductive stages of pre-conception, pregnancy and the postnatal period through qualitative interviews. Insights from existing literature alongside findings from interviews and focus groups with patients and healthcare providers to develop an intervention to address the issues and support needs as identified by study participants.
Read the detailed description
This study will be conducted in 3 phases:
Phase 1: Literature review (0-9 months). The research literature on pregnancy outcomes and factors affecting family planning decisions of women and men diagnosed with IBD will be systematically searched and reviewed. The findings will be used to prepare a topic guide to be used in the interviews with women and their partners.
Phase 2: Interview study (10-20 months). A topic guide prepared in Phase 1 will provide a structure for in-depth interviews to explore the experience of family planning by women diagnosed with inflammatory bowel disease (IBD) and their partners. Detailed face-to-face interviews will be voice recorded and transcribed verbatim. Each interview may last approximately 45-60 minutes, giving participants sufficient time to share their experience. A total of 24-30 women diagnosed with IBD will be interviewed, where possible selecting 8-10 women at different family planning stages (pre-pregnancy, pregnancy and post-delivery). 3-4 women's partners for in each group, to explore partner's perspective of the pregnancy or pre-conception experience.
Phase 3: Intervention development with focus group interview (21-24 months). The Phase 2 findings will be used to prepare a draft of the intervention to address the issues and support needs as identified by study participants. A group of patients (3-4) and healthcare practitioners (3-4) will be recruited to take part in a joint discussion (focus group interview) on intervention acceptability, and the comments will be used to further develop the intervention.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Interview
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participants will be interviewed on their experience of family planning and inflammatory bowel disease.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Women with inflammatory bowel disease (IBD. Receives: Other: Interview | |
| Partners | Partners of women with IBD. Receives: Other: Interview | |
| Healthcare Professionals | Healthcare professionals working with women with IBD. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interviews of women with inflammatory bowel disease and their partners to measure their experience and feelings related to fertility and family planning
Exploratory and qualitative in nature with no scale. Experiences of women with inflammatory bowel disease (IBD) and their partners related to fertility and family planning will be sort by interview. Descriptive outcomes will be obtained, but we do not know what they will be until we interview the participants.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start26 Jul 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725124
- Sponsor's protocol ID
- 2017GAS97
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lived Experience of Family Planning of Female Patients Diagnosed With Inflammatory Bowel Disease (IBD) and Their Partners During Key Reproductive Stages - a Qualitative Study
- ClinicalTrials.gov ID
- NCT03725124
- Acronym / sponsor ID
- 2017GAS97
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the lived experiences of family planning for women with inflammatory bowel disease (IBD) and their partners during the reproductive stages of pre-conception, pregnancy and the postnatal period through qualitative interviews. Insights from existing literature alongside findings from interviews and focus groups with patients and healthcare providers to develop an intervention to address the issues and support needs as identified by study participants.
Detailed description
This study will be conducted in 3 phases:
Phase 1: Literature review (0-9 months). The research literature on pregnancy outcomes and factors affecting family planning decisions of women and men diagnosed with IBD will be systematically searched and reviewed. The findings will be used to prepare a topic guide to be used in the interviews with women and their partners.
Phase 2: Interview study (10-20 months). A topic guide prepared in Phase 1 will provide a structure for in-depth interviews to explore the experience of family planning by women diagnosed with inflammatory bowel disease (IBD) and their partners. Detailed face-to-face interviews will be voice recorded and transcribed verbatim. Each interview may last approximately 45-60 minutes, giving participants sufficient time to share their experience. A total of 24-30 women diagnosed with IBD will be interviewed, where possible selecting 8-10 women at different family planning stages (pre-pregnancy, pregnancy and post-delivery). 3-4 women's partners for in each group, to explore partner's perspective of the pregnancy or pre-conception experience.
Phase 3: Intervention development with focus group interview (21-24 months). The Phase 2 findings will be used to prepare a draft of the intervention to address the issues and support needs as identified by study participants. A group of patients (3-4) and healthcare practitioners (3-4) will be recruited to take part in a joint discussion (focus group interview) on intervention acceptability, and the comments will be used to further develop the intervention.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: InterviewWomen with inflammatory bowel disease (IBD. |
| Partners | – | Other: InterviewPartners of women with IBD. |
| Healthcare Professionals | – | Other: InterviewHealthcare professionals working with women with IBD. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with inflammatory bowel disease (IBD), partners of women with IBD and healthcare professionals working with women with IBD will be recruited via patient groups and secondary care IBD clinics.
Key inclusion criteria (3 listed)
- Women diagnosed with IBD at different family planning stages (pre-pregnancy, pregnancy and post-partum).
- Women diagnosed with IBD's partners.
- Health practitioners involved with women diagnoses with IBD and on-going care (phase 3 only).
Key exclusion criteria (1 listed)
- Does not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewParticipants will be interviewed on their experience of family planning and inflammatory bowel disease. | Other | Healthcare Professionals, Partners, Patients |
Primary outcome
Interviews of women with inflammatory bowel disease and their partners to measure their experience and feelings related to fertility and family planning
Time frame: Up to 14 months
Exploratory and qualitative in nature with no scale. Experiences of women with inflammatory bowel disease (IBD) and their partners related to fertility and family planning will be sort by interview. Descriptive outcomes will be obtained, but we do not know what they will be until we interview the participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 9 Sep 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interviews of women with inflammatory bowel disease and their partners to measure their experience and feelings related to fertility and family planning (time frame: Up to 14 months). 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 9 Sep 2020.