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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035109
Receipt No. R000039820
Official scientific title of the study 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 2018/12/02

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Basic information
Official scientific title of the study Investigation of the efficacy and safety of laparoscopic cervico-isthmus cerclage in cases that are difficult to treat with transvaginal cervical cerclage
Title of the study (Brief title) Safe and Efficient Trial of Laparoscopic transabdominal Cervico-Isthmic Cerclage (SET-LCIC)
Region
Japan

Condition
Condition cervical incompetence
Classification by specialty
Obsterics 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 Masaaki Nagatsuka
Organization Showa University Northern Yokohama Hospital
Division name The department of obstetrics and gynecology
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 Satoshi Dohi
Organization Showa University Northern Yokohama Hospital
Division name The department of obstetrics and gynecology
Address Chigasaki-chuo 35-1, Tsuzuki-ku Yokohama-shi, Kanagawa-ken, 224-8503
TEL 045-949-7000
Homepage URL
Email satoshi.dohi1018@gmail.com

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

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

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 10 Month 25 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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.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


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