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
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
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
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
