UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035109
Receipt number R000039820
Scientific Title Investigation of the efficacy and safety of laparoscopic cervico-isthmus cerclage in cases that are difficult to treat with transvaginal cervical cerclage
Date of disclosure of the study information 2018/12/03
Last modified on 2023/01/22 14:27:20

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Basic information

Public title

Investigation of the efficacy and safety of laparoscopic cervico-isthmus cerclage in cases that are difficult to treat with transvaginal cervical cerclage

Acronym

Safe and Efficient Trial of Laparoscopic transabdominal Cervico-Isthmic Cerclage (SET-LCIC)

Scientific Title

Investigation of the efficacy and safety of laparoscopic cervico-isthmus cerclage in cases that are difficult to treat with transvaginal cervical cerclage

Scientific Title:Acronym

Safe and Efficient Trial of Laparoscopic transabdominal Cervico-Isthmic Cerclage (SET-LCIC)

Region

Japan


Condition

Condition

cervical incompetence

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In transvaginal cervical cerclage pertaining to pregnant women in whom maintenance of pregnancy is a challenge, several reports on laparoscopic cervico-isthmus cerclage (LCIC) while in the non-pregnant state have recently emerged in Japan. Although there are institutions that perform LCIC in women while in the non-pregnant state after considering the difficulty of performing laparoscopic surgery during pregnancy, cervical cerclage is generally performed during pregnancy regardless of the surgical modality. In addition, reports on cases where LCIC was performed in the non-pregnant state are rare globally. From the aspect of safety, LCIC is commonly performed post pregnancy. In Japan, LCIC per se is hardly performed regardless of the state of pregnancy. Therefore, its efficacy and safety are yet to be investigated in Japan. This study investigated the effectiveness of LCIC for prolonging pregnancy and the safety of LCIC per se to weigh the pros and cons of introducing and popularizing LCIC during pregnancy in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Prolonging pregnancy: especially prolonging pregnancy after 34 weeks of gestational age

Key secondary outcomes

Neonatal prognosis and neonatal information.
For example, height, weight, Apgar score etc.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic Cervico-isthmic Cerclage: LCIC

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

16 years-old <=

Age-upper limit

55 years-old >=

Gender

Female

Key inclusion criteria

1)A pregnant patient with cervical incompetency.
The clinical conditions listed below are the specific targets identified:
1.Patients with loss of the uterine cervix after uterine conization
2.Women with uterine cervix cleavage
3.Women with vaginal deformation due to laceration of the cervix
4.Women who had a premature delivery despite having undergone transvaginal cervical cerclage in the past
5.Women with cervical incompetency occurring in the first and/or second trimesters of pregnancy
6.Women with a history of premature delivery at a gestational age of <34 weeks or shortening of the cervical length (<25 mm) confirmed on transvaginal ultrasonography in the early pregnancy period.
7.A patient judged by the medical officer responsible for performing the treatment and the attending physician as requiring such treatment

2)A patient who is at least 16 years old but <55 years old at the time of giving her consent.
3)A patient who personally gives her written informed consent to participate in this study. In the event that the age of the patient is <20 years, a written informed consent must be obtained from the legally acceptable representative of the patient.
4)A patient who is eligible for this study is confirmed by several specialists and will be selected carefully once the safety of the patient is ensured.

Key exclusion criteria

1) A pregnant woman for whom LCIC is judged to be impossible to perform because of intense intra-abdominal adhesion
2) A pregnant woman with intrauterine fetal death prior to LCIC
3) A pregnant woman judged to be in a state with a high possibility of the fetus aborting before LCIC
4) A pregnant woman with a coexisting malignant tumor
5) A pregnant woman judged by the principal investigator as not eligible to participate in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Masaaki
Middle name
Last name Nagatsuka

Organization

Showa University Northern Yokohama Hospital

Division name

The department of obstetrics and gynecology

Zip code

224-8503

Address

Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503

TEL

045-949-7000

Email

masa-nagat@mail.goo.ne.jp


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Seo

Organization

Showa University Northern Yokohama Hospital

Division name

The department of obstetrics and gynecology

Zip code

224-8503

Address

Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503

TEL

045-949-7000

Homepage URL


Email

seo@med.showa-u.ac.jp


Sponsor or person

Institute

The department of obstetrics and gynecology, Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Obstetrics and Gynecology
Showa University School of Medicine

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Showa University School of Medicine

Address

35-1, Chigasakichuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, 224-8503, Japan

Tel

045-949-7175

Email

irb02syh@ofc.showa-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

昭和大学横浜市北部病院(神奈川県)
Showa University Northern Yokohama Hospital, Kanagawa
昭和大学病院(東京都)
Showa University Hospital


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 03 Day


Related information

URL releasing protocol

1

Publication of results

Unpublished


Result

URL related to results and publications

1

Number of participants that the trial has enrolled

30

Results

1

Results date posted

2023 Year 01 Month 22 Day

Results Delayed

Delay expected

Results Delay Reason

Small sample

Date of the first journal publication of results


Baseline Characteristics

1

Participant flow

1

Adverse events

None

Outcome measures

1

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 10 Month 25 Day

Date of IRB

2017 Year 11 Month 20 Day

Anticipated trial start date

2017 Year 11 Month 20 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 09 Month 30 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 02 Day

Last modified on

2023 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name