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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001870
Receipt No. R000002251
Scientific Title Validation of efficacy of cervical cerclage in patients with short cervical length
Date of disclosure of the study information 2009/04/20
Last modified on 2012/08/26

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Basic information
Public title Validation of efficacy of cervical cerclage in patients with short cervical length
Acronym Efficacy of cervical cerclage (RCT)
Scientific Title Validation of efficacy of cervical cerclage in patients with short cervical length
Scientific Title:Acronym Efficacy of cervical cerclage (RCT)
Region
Japan

Condition
Condition Pregnant women with subclinical infection and cervical length 25 mm as diagnosed by transvaginal ultrasonography in a maternity health examination conducted during the second trimester of pregnancy (between week 16 day 0 and week 26 day 6 of gestation)
Classification by specialty
Obsterics and gynecology Pediatrics Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy and safety of cervical cerclage for the purpose of preventing preterm delivery in pregnant women with short cervical length and no subclinical infection in the second trimester of pregnancy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Gestational week of delivery
Neonatal mortality rate
Neonatal morbidity
Key secondary outcomes Percentage of patients using a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation)
Mean birth weight

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group receiving McDonald cervical cerclage
Interventions/Control_2 Group receiving Shirodkar cervical cerclage
Interventions/Control_3 Bed-rest therapy
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 (1) Pregnant women between week 16 day 0 and week 26 day 6 of gestation
(2) Cervical length less than 25.0 mm as diagnosed by transvaginal ultrasonography
(3) Pregnant women testing positive for subclinical infection*1 who do not have infection that could potentially determine the mode of delivery (such as HIV, HSV, or condyloma, etc.)
(4) Patients who have voluntarily provided written consent to participate in this trial, after having been thoroughly briefed, and informed of the nature of the trial (if the patient is under 20 years old, written consent must be obtained from the spouse (if the spouse is younger than 20 years old) or parent of the minor)
(5) Patients with stable functionality of major organs, confirmed by meeting the following laboratory test standards:
1)White blood cell count ≥3,000/mm3, ≤20,000/mm3
2) Red blood cell count ≥50,000/mm3
3) Hemoglobin ≥8.0g/dL
4)AST (GOT) <2.5 times upper limit of standard level of each test center
5) ALT (GPT) <2.5 times upper limit of standard level of each test center
6) BUN &#8804;25 mg/dL
7) Serum creatinine &#8804;2 mg/dL
Key exclusion criteria (1) Multiple pregnancy involving more than 3 fetuses
(2) Placenta previa
(3) Premature separation of normally implanted placenta
(4) Serious fetal abnormality
(5) Patients in whom fetal well-being cannot be confirmed
(6) Patients who previously underwent cervical cerclage during current pregnancy
(7) Patients with signs of threatened premature delivery*2
(8) Patients with complications of psychiatric disease or psychiatric symptoms whose participation in the trial is judged to be infeasible
(9) Other patients judged to be ineligible by attending physician
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Okai
Organization Dept Obstetrics and Gynecology, Showa University
Division name Obstetrics and Gynecology
Zip code
Address 1-5-8 Hatanodai, Shinagawa, Tokyo,142-8555, JAPAN
TEL 03-3784-8000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norio SHINOZUKA
Organization Showa University
Division name Obstetrics anc Gynecology
Zip code
Address 1-5-8 Hatanodai, Shinagawa, Tokyo,142-8555, JAPAN
TEL 03-3784-8000
Homepage URL http://square.umin.ac.jp/topp
Email shinoz-tky@umin.ac.jp

Sponsor
Institute Japan Organization of Prevention of Preterm Delivery
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare: Multidisciplinary Research Project on Children and Family
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 04 Month 20 Day

Related information
URL releasing protocol http://square.umin.ac.jp/topp
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 Completed
Date of protocol fixation
2005 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2012 Year 08 Month 02 Day
Date of closure to data entry
2012 Year 08 Month 02 Day
Date trial data considered complete
2012 Year 08 Month 25 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 10 Day
Last modified on
2012 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002251

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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