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NCT03091309
Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease
NA trial testing Interactive educational video in Inflammatory Bowel Diseases in 220 participants. Status unknown.
1 October 2020
Quick facts
| Lead sponsor | Mount Sinai Hospital, Canada |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 220 |
| Start date | 1 October 2017 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Interactive educational video
- Initial in-person counseling with an IBD nurse
- Motivational interviewing
- Telemedicine-based follow-up
- Monthly follow-up questionnaires
- Comprehensive questionnaires
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Medication Adherence — all drugs for Medication Adherence →
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Mount Sinai Hospital, Canada
Who can join
18 and older, female only, with Inflammatory Bowel Diseases or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because the risk of IBD is greatest during the third decade of life, its impact for women is during the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of adverse outcomes during pregnancy as compared to the general population. Pregnancy is an especially vulnerable time for women with IBD, and out of misguided concerns that medications may confer unnecessary harms to their fetus, many women often stop taking life savings medications; without realizing that this sub-optimal adherence could actually lead to life threatening complications for them and their fetus. Counseling pregnant women with IBD is therefore an important step in improving medication adherence. The investigators hypothesize that counseling sessions with an IBD nurse that incorporates motivational interviewing and telemedicine-based follow-up sessions tailored to individual needs will improve medication adherence and pregnancy outcomes. The following specific aims are to be addressed by this multi-center randomized clinical trial comparing individual nurse-based counseling to standard of care: Specific Aim #1: To assess whether patient-centered counseling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication adherence during pregnancy and pregnancy outcomes Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy in the IBD population
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Psychological interventions for treatment of inflammatory bowel disease.
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, et al · · 2025 · cited 5× · PMID 40243391 · DOI 10.1002/14651858.cd006913.pub3
Verify or expand the search:
- PubMed search for NCT03091309
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03091309 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mount Sinai Hospital, Canada
- Last refreshed: 19 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03091309.
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