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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043613
Receipt No. 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 2021/07/14

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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
Obsterics 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 two weeks later
Key secondary outcomes the percentage of cephalic presentation four weeks later, six weeks later, and at delivery, the rate of cesarean delivery, the rate of cesarean delivery for breech presentation, 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 180

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
Email 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
Email h-shimmura@nms.ac.jp

Sponsor
Institute Nippon Medical School Department of Obstetrics and Gynecology
Institute
Department

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
Email 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
2021 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049800

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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