UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052370 |
|---|---|
| Receipt number | R000059728 |
| Scientific Title | Pregnancy outcomes in patients with Behcet's disease: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2023/10/02 09:55:24 |
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Basic information
Public title
Pregnancy outcomes in patients with Behcet's disease: a systematic review and meta-analysis
Acronym
Pregnancy outcomes in patients with Behcet's disease: a systematic review and meta-analysis
Scientific Title
Pregnancy outcomes in patients with Behcet's disease: a systematic review and meta-analysis
Scientific Title:Acronym
Pregnancy outcomes in patients with Behcet's disease: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Behcet's disease
Classification by specialty
| Clinical immunology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Behcet's disease is a chronic recurrent systemic inflammatory disease with four main symptoms: oral aphthous ulcers, genital ulcers, skin symptoms, and uveitis. Traditionally, the disease was thought to be more common in males, but recent surveys have shown a female predominance, and perinatal prognosis is still unclear. Therefore, we will conduct a systematic review and meta-analysis to evaluate the pregnancy outcomes in Behcet's disease patients and to compare them with healthy controls.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome: The primary endpoints are miscarriage, premature delivery and fetal growth restriction. The odds ratio (OR) will be calculated. Meta-analysis will be performed to compare the incidence of co-primary outcomes between FMF patients and healthy controls.
Key secondary outcomes
The secondary outcomes are hypertensive disorders, caesarean delivery and fetal anomaly.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Case-control studies, cohort studies, and randomized clinical trials will be eligible.
(2) Studies with clinically diagnosed Behcet's disease will be eligible.
(5) Studies describing pregnancy outcomes in Behcet's disease.
Key exclusion criteria
(1) A systematic review or meta-analysis article.
(2) Case reports or case series with fewer than 5 cases.
(3) Republished research literature will be excluded unless it contains new findings related to pregnancy outcomes.
(4) Studies published in a language other than English.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Graduate School of Medicine
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in October 2023. A hand search will be conducted by two investigators.
Participants: The patients were clinically diagnosed with Behcet's syndrome.
Intervention: No intervention.
Comparison: Healthy control.
Outcome: Incidence of adverse pregnancy outcomes.
Two investigators independently will screen all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
The risk of bias of each study will be assessed by the Newcastle-Ottawa Scale for cohort studies.
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059728
