Family Planning in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725124
• Other study ID #: 2017GAS97
• Status: Completed
• Start date: July 26, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2020
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Interview
Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 14 months