UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028518 |
|---|---|
| Receipt number | 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 09:27:10 |
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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
| Obstetrics 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
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
daisukeh@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032633
