UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	daisukeh@gunma-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Gunma University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044569