UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043613 |
|---|---|
| Receipt number | R000049800 |
| Scientific Title | A randomized controlled trial of cephalic version for breech presentation in the third trimester by lateral postural management without knee-chest position |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2022/06/19 20:49:02 |
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Basic information
Public title
A randomized controlled trial of cephalic version for breech presentation in the third trimester by lateral postural management without knee-chest position
Acronym
BRLT study
Scientific Title
A randomized controlled trial of cephalic version for breech presentation in the third trimester by lateral postural management without knee-chest position
Scientific Title:Acronym
BRLT study
Region
| Japan |
Condition
Condition
Breech presentation
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the significance of postural management of the lateral position for breech presentation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
the percentage of fetuses in cephalic presentation at term
Key secondary outcomes
the percentage of cephalic presentation two weeks later, four weeks later, six weeks later, and at delivery, the rate of cesarean delivery, the rate of cesarean delivery for breech presentation, recurrent breech presentation after cephalic version, and adverse effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Women of the interventional group are going to be instructed to lie on their right side several times a day when the fetal back was left side, or to lie on their left side when the fetal back was right side. After cephalic version, they are going to be instructed the other side. Other genupectoral management is not recommended.
Interventions/Control_2
Women of the control group are going to receive expectant management care complying with Guidelines for obstetrical practice in Japan 2020.
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 who are diagnosed with breech presentation by ultrasonography between 28 weeks 0 days and 30 weeks 0 days of gestation at a single institution were eligible for inclusion.
Key exclusion criteria
The exclusion criteria were scheduled cesarean delivery (included placenta previa, history of cesarean delivery, and history of myomectomy), multiple pregnancy, transverse position, scheduled delivery at another hospital, other genupectoral management, and complications such as heart disease.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Shinmura |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
211-8533
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-733-5181
h-shimmura@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Shinmura |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
211-8533
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-733-5181
Homepage URL
h-shimmura@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The ethics committee of Nippon Medical School Musashikosugi Hospital
Address
1-396 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa, Japan
Tel
044-733-5181
y-shibanuma@nms.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
日本医科大学武蔵小杉病院／Nippon Medical School Musashikosugi Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.nms.ac.jp/kosugi-h.html
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 03 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049800
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
