UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000032633