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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027215
Receipt No. R000031181
Scientific Title The mechanism of pregnancy and labor affecting pelvic organ prolapse
Date of disclosure of the study information 2018/03/01
Last modified on 2019/04/23

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Basic information
Public title The mechanism of pregnancy and labor affecting pelvic organ prolapse
Acronym The mechanism of pregnancy and labor affecting POP
Scientific Title The mechanism of pregnancy and labor affecting pelvic organ prolapse
Scientific Title:Acronym The mechanism of pregnancy and labor affecting POP
Region
Japan

Condition
Condition Pelvic organ prolapse
Classification by specialty
Obsterics and gynecology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pelvic organ prolapse POP is a hernia of the pelvic floor caused by damage of the pelvic floor muscle group and the internal pelvic fascia due to pregnancy, childbirth. It is classified as cystocele, uterine prolapse, rectocele, enterocele, vaginal stump prolapse.
POP reduces patient's QOL significantly because of the symptoms such as discomfort in the lower abdomen, increase vaginal secretion, vaginal mucosal erosion Urinary retention or constipation.
On the other hand, since fundamentally it will not lead to death, it is hardly treated for a long time, and it is said that few patients were consulted from shame. However, in recent years, POP patients has been on an increasing in Japan by changes in consciousness to health care. Statistically it is said that prolapse is seen in almost 30 percent to 50 percent of parouse women, but it is only recognized empirically how pregnancy and childbirth wound the vaginal wall.
As a mechanism of POP, DeLancey reported by using anatomical specimens that the damage to the three sites on the pulling and supporting of the vaginal wall around the vaginal canal. On the other hand, there is no report on what pregnancy and childbirth causes damage to the vaginal wall and affect future POP.
It is expected to lead to prediction and prevention of future uterine prolapse by analyzing the change of the vaginal wall from pregnancy to postpartum, reveal the mechanism of injury and examining the relationship with uterine prolapse.
Today, as a treatment method, the mesh-using surgery has been established. However mesh surgery has not been obtained In particular about mesh size and place, and it is due to the experience of the practitioner. By analyzing the damaging mechanism of the vaginal wall in this study, establishment of a more effective technique is expected.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in vaginal wall length by transperineal ultrasonography at the beginning of pregnancy, middle stage, late stage, 1 month postpartum.
Key secondary outcomes Anatomical changes in the pelvis including inclination of vaginal wall and cystourethral angle. presence or absence of pregnancy complications and changes of cervical length

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Measurement of change of pelvic floor by transperineal ultrasonography from the first trimester to postpertum
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
15 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria Pregnant women visited to our hospital at the first trimester were enrolled in this study. Informed consent were obtained from all patients.
Key exclusion criteria Previous operation of pelvic organ prolapse, Previous operation of uterus
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tsuyoshi
Middle name
Last name Ishida
Organization Kawasaki Medical School
Division name Department of Obstetrics and Gynecology
Zip code 701-0192
Address Matsushima 577, Kurashiki city
TEL 086-462-1111
Email k0106142@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Ishida
Organization Kawasaki Medical School
Division name Department of Obstetrics and Gynecology
Zip code 701-0192
Address Matsushima 577, Kurashiki city
TEL 086-462-1111
Homepage URL
Email k0106142@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical School
Address Matsushima 577, Kurashiki city
Tel 0.0586-462-1111
Email k0106142@med.kawasaki-m.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
2018 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 01 Day
Date of IRB
2018 Year 03 Month 24 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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