UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013637 |
|---|---|
| Receipt number | R000015918 |
| Scientific Title | Pregnancy outcome in patients with inflammatory bowel disease besed on detailed questionnaires |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2024/05/21 19:04:00 |
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Basic information
Public title
Pregnancy outcome in patients with inflammatory bowel disease besed on detailed questionnaires
Acronym
Pregnancy outcome in patients with inflammatory bowel disease
Scientific Title
Pregnancy outcome in patients with inflammatory bowel disease besed on detailed questionnaires
Scientific Title:Acronym
Pregnancy outcome in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare pregnancy outcomes in IBD patients between who used biologics and/or immunomodulator and who did not.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
pregnanvy outcome
congenital abnormality
Key secondary outcomes
low birth weight
preterm birth
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
patients who received IM or Bio while they were at the beginning of pregnancy
aged matched control
Key exclusion criteria
without agreement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Miura |
Organization
national defense medical college
Division name
internal medicine
Zip code
3598513
Address
3-2 namiki tokorozawa
TEL
04-2995-1609
miura@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | ryota |
| Middle name | |
| Last name | hokari |
Organization
national defense medical college
Division name
internal medicine
Zip code
3598513
Address
3-2 namiki tokorozawa
TEL
04-2995-1609
Homepage URL
ryota@ndmc.ac.jp
Sponsor or person
Institute
national defense medical college
Institute
Department
Personal name
Funding Source
Organization
national defense medical college
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
National Defense Medical College, by Intractable Diseases, the Health and Labour Sciences Research Grants from Ministry of Health, Labour and Welfare
Name of secondary funder(s)
National Defense Medical College, by Intractable Diseases, the Health and Labour Sciences Research Grants from Ministry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
National Defense Medical College
Address
Namiki-3-2
Tel
0429951609
ryota@ndmc.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
944
Org. issuing International ID_1
national defense medical college
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
防衛医科大学校病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4863047/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4863047/
Number of participants that the trial has enrolled
72
Results
35 of the 41 pregnancies that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks.
Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality.
6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment.
Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions.
Results date posted
| 2024 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were treated in the hospitals of Members of the Japanese study group for pregnant women with IBD were enrolled. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines
Participant flow
Between September 2008 and March 2014, a multicenter, cross-sectional study was conducted.
Adverse events
No
Outcome measures
Pregnancy outcomes, pontaneous abortion, preterm birth, LBW, and congenital malformations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 02 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 03 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 04 | Day |
Other
Other related information
retrospective
case control
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015918
