UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027215 |
|---|---|
| Receipt number | 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 | 2022/04/25 10:54:32 |
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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
| Obstetrics 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
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
k0106142@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031181
