UMIN-CTR Clinical Trial

Basic information
Public title	The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Acronym	The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Scientific Title	The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Scientific Title:Acronym	The investigation for the real state and prognosis of cervical cerclage to prevent preterm birth
Region	Japan

Condition
Condition	Cervical incompetency
Classification by specialty	Obsterics and gynecology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The investigation of the efficacy of cervical cerclage for cervical incompetency
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The analysis of factors involved in the successful cervical cerclage
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women who underwent cerclage from 12 to 25 weeks gestation in four perinatal medical centers between January 2009 and December 2010
Key exclusion criteria	Prognosis unknown and multiple pregnant women
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Shibata
Organization	University of Occupational and Environmental Health
Division name	Department of Obstetrics and Gynecology
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-city, Fukuoka, JAPAN
TEL	093-603-1611
Email	age-s@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Shibata
Organization	University of Occupational and Environmental Health
Division name	Department of Obstetrics and Gynecology
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-city, Fukuoka, JAPAN
TEL	093-603-1611
Homepage URL
Email	age-s@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization	University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Occupational and Environmental Health
Address	1-1 Iseigaoka, Yahatanishi-k, Kitakyushu-city, Fukuoka, JAPAN
Tel	0936031611
Email	age-s@med.uoeh-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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 28 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	114
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	No longer recruiting
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 10 Month 01 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	WBC(/ul) CRP(mg/dl) Gestational weeks at cerclage Pre-cerclage Cervical length(mm) The rate of Prophylactic cerclage The rate of Therapeutic cerclage Blood loss of operation(g) Operation time(min) Post-cerclage Cervical length(mm) Cervical length from suture to EOS(mm) Hospitalization(day) Duration of RIT use(day) Pregnancy latency(day)

Management information
Registered date	2022 Year 03 Month 28 Day
Last modified on	2022 Year 03 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053943