Family Planning in Inflammatory Bowel Disease

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03725124
Study type	Observational
Source	The Royal Wolverhampton Hospitals NHS Trust
Contact
Status	Completed
Phase
Start date	July 26, 2018
Completion date	January 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04046913` - The ADDapt Diet in Reducing Crohn's Disease Inflammation	N/A
Active, not recruiting	`NCT04989907` - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Active, not recruiting	`NCT04990258` - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed	`NCT06216223` - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients	N/A
Enrolling by invitation	`NCT06015789` - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting	`NCT06065995` - StoMakker Mobile Application	N/A
Recruiting	`NCT03282786` - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease	N/A
Recruiting	`NCT06002074` - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT04960826` - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting	`NCT05413941` - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease	N/A
Completed	`NCT03668249` - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed	`NCT00721812` - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686	Phase 1
Recruiting	`NCT05809999` - IBD Neoplasia Surveillance RCT	N/A
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Recruiting	`NCT04991324` - Cholecalciferol Comedication in IBD - the 5C-study	Phase 3
Completed	`NCT03173144` - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting	`NCT05043818` - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT02874365` - Intestinal Stem Cells Characterization	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.