UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039099 |
|---|---|
| Receipt number | R000044569 |
| Scientific Title | The study between endometriosis/uterus adenomyosis and perinatal prognosis |
| Date of disclosure of the study information | 2020/01/14 |
| Last modified on | 2022/07/12 10:27:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study between endometriosis/uterus adenomyosis and perinatal prognosis
Acronym
The study between endometriosis/uterus adenomyosis and perinatal prognosis
Scientific Title
The study between endometriosis/uterus adenomyosis and perinatal prognosis
Scientific Title:Acronym
The study between endometriosis/uterus adenomyosis and perinatal prognosis
Region
| Japan |
Condition
Condition
endometriosis
uterus adenomyosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the perinatal prognosis of pregnant women diagnosed with endometriosis and uterus adenomyosis by clinical diagnosis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms and findings of endometriosis and uterine adenomyosis
Placental malposition
Key secondary outcomes
Symptoms and findings of endometriosis and uterine adenomyosis
Premature birth, Small for gestational age, miscarriage, preeclampsia, gestational diabetes, etc.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
only age
Key exclusion criteria
none
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Iwase |
Organization
Gunma University Hospital
Division name
Obstetrics and Gynecology
Zip code
3718511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7111
daisukeh@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Higeta |
Organization
Gunma University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
3718511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-7111
Homepage URL
daisukeh@gunma-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Gunma University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
daisukeh@gunma-u.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
群馬大学医学部附属病院、群馬県立小児医療センター、前橋赤十字病院、JCHO群馬中央病院、高崎総合医療センター、公立藤岡総合病院、公立富岡総合病院、桐生厚生総合病院、伊勢崎市民病院（すべて群馬県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Interviews (age, height, non-pregnant weight, history(smoking, medication, pregnancy, delivery, previous, family, endometriosis surgery), pregnancy method, symptoms when menstruation, pre- and post-pregnancy) ,Surgical examination (uterine flexion, uterine movement, ovarian enlargement, tenderness around ovary, ovarian movement, Douglas fossa induration) , Trans-vaginal ultrasonography (uterine flexion, measurement of uterus myometrium, fluid retention in Douglas fossa, bilateral ovarian measurement, deep endometriosis).
Management information
Registered date
| 2020 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044569
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
