Pregnancy in Greek Female Patients With Inflammatory Bowel Disease - Panhellenic Recording
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of the present study is to retrospectively record all the successful pregnancies in Greek IBD patients within the last 10 years and prospectively record all the future pregnancies for the next 4 years. Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy, pregnancy outcomes, delivery mode, lactation and health status of the offspring. Moreover, the management of the pregnant IBD patients in Greece will be analyzed and compared to the European guidelines, in an effort to develop a position statement applicable to the Greek NHS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
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
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 28, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedFebruary 2, 2023
January 1, 2023
4 years
September 28, 2022
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Data will be obtained regarding IBD clinical parameters, before, during and after the pregnancy.
the management of the pregnant IBD patients in Greece
01/01/2020-31/12/2023
Data will be obtained regarding IBD pregnancy outcomes and delivery mode.
the management of the pregnant IBD patients in Greece
01/01/2020-31/12/2023
Data will be obtained regarding lactation and health status of the offspring.
the management of the pregnant IBD patients in Greece
01/01/2020-31/12/2023
Eligibility Criteria
Female pregnant IBD patients in Greece
You may qualify if:
- Patients pregnant with Inflammatory Bowel Disease
- patients age \>18 years with IBD
You may not qualify if:
- Termination of pregnancy in the first trimester
- Miscarriage of pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandra General Hospital Greece
Athens, 11528, Greece
Related Publications (1)
Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE, Cohen RD, Chambers CD, Sandborn WJ; Crohn's Colitis Foundation Clinical Research Alliance. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038. Epub 2020 Nov 21.
PMID: 33227283RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Gastroenterology Department Alexandra General Hospital Athens Greece
Study Record Dates
First Submitted
September 28, 2022
First Posted
October 3, 2022
Study Start
January 1, 2020
Primary Completion
December 31, 2023
Study Completion
July 1, 2024
Last Updated
February 2, 2023
Record last verified: 2023-01