UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031181