Family Planning in Inflammatory Bowel Disease

NCT ID: NCT03725124

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2020-01-31

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

Women with inflammatory bowel disease (IBD.

Interview

Intervention Type: OTHER

Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Partners

Partners of women with IBD.

Interview

Intervention Type: OTHER

Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Healthcare Professionals

Healthcare professionals working with women with IBD.

Interview

Intervention Type: OTHER

Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Interventions

Interview

Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• Does not consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Wolverhampton NHS Trust

Wolverhampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

2017GAS97

Identifier Type: -

Identifier Source: org_study_id