NCT03725124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

October 29, 2018

Last Update Submit

September 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Patients

Women with inflammatory bowel disease (IBD.

Other: Interview

Partners

Partners of women with IBD.

Other: Interview

Healthcare Professionals

Healthcare professionals working with women with IBD.

Other: Interview

Interventions

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

Healthcare ProfessionalsPartnersPatients

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with inflammatory bowel disease (IBD), partners of women with IBD and healthcare professionals working with women with IBD will be recruited via patient groups and secondary care IBD clinics.

You may qualify if:

  • 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).

You may not qualify if:

  • Does not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 30, 2018

Study Start

July 26, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations