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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031586
Receipt No. R000036028
Scientific Title Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Date of disclosure of the study information 2018/03/05
Last modified on 2019/04/16

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Basic information
Public title Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Acronym Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Scientific Title Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Scientific Title:Acronym Trial of prevention of preterm birth in pregnancy after preterm birth by progesterone
Region
Japan

Condition
Condition pregnancy after preterm birth
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether progesterone prevent preterm birth in pregnancy after preterm birth
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of preterm birth
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Injection of progesterone 250mg into muscle once weekly between 16 and 36 weeks of gestations
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria pregnancy women after preterm birth
Key exclusion criteria 1) prior preterm birth by induction for obstetrics complication
2) contraindication of progesterone
3) multiple pregnancy
4) fetus of severe anomaly or abnormal chromosome
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Mizoguchi
Organization Wakayama Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 811-1, Kimiidera, Wakayama City
TEL 073-441-0631
Email ma-mika@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Mizoguchi
Organization Wakayama Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 811-1, Kimiidera, Wakayama City
TEL 073-441-0631
Homepage URL
Email ma-mika@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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
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
2018 Year 03 Month 05 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
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
2018 Year 02 Month 13 Day
Date of IRB
2018 Year 02 Month 13 Day
Anticipated trial start date
2018 Year 02 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036028

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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