Family Planning in Inflammatory Bowel Disease

Sponsor

The Royal Wolverhampton Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03725124

Collaborator

(none)

Enrollment

Location

18.2

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Other: Interview

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

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Jul 26, 2018

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients Women with inflammatory bowel disease (IBD.	Other: Interview Participants will be interviewed on their experience of family planning and inflammatory bowel disease.
Partners Partners of women with IBD.	Other: Interview Participants will be interviewed on their experience of family planning and inflammatory bowel disease.
Healthcare Professionals Healthcare professionals working with women with IBD.	Other: Interview Participants will be interviewed on their experience of family planning and inflammatory bowel disease.

Arm

Intervention/Treatment

Patients

Women with inflammatory bowel disease (IBD.

Other: Interview

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

Partners

Partners of women with IBD.

Other: Interview

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

Healthcare Professionals

Healthcare professionals working with women with IBD.

Other: Interview

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

Outcome Measures

Primary Outcome Measures

Interviews of women with inflammatory bowel disease and their partners to measure their experience and feelings related to fertility and family planning [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Wolverhampton NHS Trust	Wolverhampton		United Kingdom	WV10 0QP

Sponsors and Collaborators

The Royal Wolverhampton Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Royal Wolverhampton Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT03725124

Other Study ID Numbers:

2017GAS97

First Posted:

Oct 30, 2018

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Sep 9, 2020