MedTrace Logo

The Safety Assessment of Vedolizumab During Pregnancy in IBD Patient

NCT02617927 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-05-02

No results posted yet for this study

Summary

The safety assessment of Vedolizumab during pregnancy in IBD patients.

The primary objective of this study is:

1. To quantify incidence of major structural birth defects and other birth outcomes in infants born to women with UC/CD with exposure to Entyvio compared to women with exposure to other biological agents or conventional IBD therapy during pregnancy
2. To assess the health and developmental status of infants up to 1yr of age.

Conditions

  • Pregnancy Complications

Sponsors & Collaborators

  • Ariella Shitrit

    lead OTHER

Principal Investigators

  • Eran Goldin, Professor · Shaarey Zedek MC

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2021-03-31
Completion
2021-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617927 on ClinicalTrials.gov