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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028518
Receipt No. R000032633
Scientific Title Invasive interventional study on the effectiveness of Hydroxyprogesterone caproate for pregnant women with previous spontaneous miscarriage or premature birth
Date of disclosure of the study information 2017/08/31
Last modified on 2019/08/05

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Basic information
Public title Invasive interventional study on the effectiveness of Hydroxyprogesterone caproate for pregnant women with previous spontaneous miscarriage or premature birth
Acronym Invasive interventional study on the effectiveness of 17p for pregnant women with previous spontaneous miscarriage or premature birth
Scientific Title Invasive interventional study on the effectiveness of Hydroxyprogesterone caproate for pregnant women with previous spontaneous miscarriage or premature birth
Scientific Title:Acronym Invasive interventional study on the effectiveness of 17p for pregnant women with previous spontaneous miscarriage or premature birth
Region
Japan

Condition
Condition threatened miscarriage
threatened premature labor
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will clarify the efficacy and the safety of 17p by administering 17p to pregnant women with previous spontaneous miscarriage and premature birth.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the risk of delivery at less than 32 weeks, delivery at less than 34 weeks and delivery at less than 37 weeks.
Key secondary outcomes cervical length and the risk of adverse event

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After informed consent, 17p(250mg) is administered once a week until 36 weeks gestation. Cervical cerclage is prohibited during the study period. It does not increase or decrease the dose of 17p.
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 1) Pregnant women
2) Women with previous spontaneous miscarriage or premature birth
3) Inpatients and outpatients
4) Patients agreeing to this study in writing
Key exclusion criteria 1) Women with artificial abortion or premature birth
2) Patients with bleeding tendency
3) Dialysis patients
4) Patients with severe mental illness
5) Severe diabetic patients with HbA1c(NGSP)>10%
6) Other patients who are inappropriate for the study according to the judgement of the doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kishi
Organization Gunma University Hospital
Division name Obstetrics and gynecology
Zip code 371-8511
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8429
Email daisukeh@gunma-u.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Higeta
Organization Gunma University Hospital
Division name Obstetrics and gynecology
Zip code 371-8511
Address 3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8429
Homepage URL
Email daisukeh@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Gunma University Hospital
Obstetrics and gynecology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization IRB, Gunma university hospital
Address 3-39-15,Showa-machi,Maebashi-shi,Gunma
Tel 027-220-8740
Email gunmaciru-office@umin.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 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 31 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 0
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 Terminated
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
2017 Year 07 Month 07 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 06 Month 30 Day
Date trial data considered complete
2022 Year 07 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032633

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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