UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023080 |
|---|---|
| Receipt number | R000026565 |
| Scientific Title | Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2017/07/27 13:21:16 |
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Basic information
Public title
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Acronym
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Scientific Title
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Scientific Title:Acronym
Trial of prevention of preterm birth in women with prior preterm birth by vaginal progesterone
Region
| Japan |
Condition
Condition
pregnant women at high risk of preterm birth
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the administration of vaginal progesterone in women with prior preterm birth after second trimester prevents 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
Administration of vaginal progesterone capsule (200mg/dl) once daily between 16 and 34 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
women with prior preterm birth after second trimester
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 | Yuka Sato |
Organization
Kyushu university hospital
Division name
Comprehensive Maternity and Perinatal Care Center
Zip code
Address
3-1-1, Maidashi, Higashi-ku,Fukuoka
TEL
092-641-1151
s-yuka@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Sato |
Organization
Kyushu university hospital
Division name
Comprehensive Maternity and Perinatal Care Center
Zip code
Address
3-1-1, Maidashi, Higashi-ku,Fukuoka
TEL
092-641-1151
Homepage URL
s-yuka@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu university hospital
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
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
| 2016 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2017 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026565
