Clinical Trials Directory

Trials / Completed

CompletedNCT03725124

Family Planning in Inflammatory Bowel Disease

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

Status
Completed
Phase
Study type
Observational
Enrollment
31 (actual)
Sponsor
The Royal Wolverhampton Hospitals NHS Trust · Other Government
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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

Interventions

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

Timeline

Start date
2018-07-26
Primary completion
2020-01-31
Completion
2020-01-31
First posted
2018-10-30
Last updated
2020-09-09

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03725124. Inclusion in this directory is not an endorsement.