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

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 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

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

Value
https://center6.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