UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053959 |
|---|---|
| Receipt number | R000061587 |
| Scientific Title | Selective Reduction Trial |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/03/29 12:49:30 |
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Basic information
Public title
Early Safety Trial of Reduction Surgery in Multiple Pregnancies
Acronym
SGT
Scientific Title
Selective Reduction Trial
Scientific Title:Acronym
SGT
Region
| Japan |
Condition
Condition
Multiple prengancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the safety of reduction surgery techniques in Japan for reducing risks to both maternal and fetal health and improving perinatal outcomes in cases of multiple pregnancies. This involves examining complications, outcomes, as well as patient backgrounds including psychological aspects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful rate of selective reduction surgery on the day after the operation
Key secondary outcomes
1. Number of surviving fetuses one week after the surgery.
2. Psychological evaluation of subjects one week after the surgery.
3. Number of adverse events occurring within one week post-surgery.
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
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Reduction surgery is performed by puncturing the uterus with a needle guided by transabdominal ultrasound between the 11th and 13th weeks of pregnancy and injecting potassium chloride into the fetal heart cavity.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1. Pregnant women who have visited our department before 14 weeks of gestation.
2. Individuals who, along with their partners, are capable of providing written consent for participation in the clinical study.
3. Participants aged 18 or older but younger than 50, with partners aged 18 or older.
4. Individuals with complications expected to significantly harm maternal health if the pregnancy continues, such as high-order multiple pregnancies or twin pregnancies.
5. Individuals without genital bleeding.
6. Individuals without ruptured membranes.
7. Individuals with a cervical length of 20 mm or more.
Key exclusion criteria
1. Individuals who test positive for HIV antibodies, HCV antibodies, or HBs antigen.
2. Individuals with psychiatric illness or symptoms that make participation in and continuation of the trial difficult.
3. Individuals with poor overall health status, classified under the American Society of Anesthesiologists Preoperative Physical Status Classification as ASA-PS Class 3, 4, 5, or 6.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Endo |
Organization
Osaka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
Yamadaoka 2-15, Suita, Osaka
TEL
0668793355
mendoh@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Mimura |
Organization
Osaka University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
565-0871
Address
Yamadaoka 2-15, Suita, Osaka
TEL
0668793355
Homepage URL
mimura@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The University of Osaka
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
Ethical Review Board Osaka University Hospital
Address
Yamadaoka 2-2, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061587
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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