UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study of vaginal and cesarean deliveries in the single tertiary center.
Title of the study (Brief title)	A retrospective study of vaginal and cesarean deliveries
Region	Japan

Condition
Condition	vaginal and cesarean deliveries
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Tabulated analysis of perinatal prognosis of vaginal and cesarean deliveries
Basic objectives2	Others
Basic objectives -Others	Analysis of perinatal prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Statistical analysis
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	pregnant women and her children
Key exclusion criteria	Those who decline to participate in this study
Target sample size	12000

Research contact person
Name of lead principal investigator	Masahiko Nakata
Organization	Toho University Omori Medical Center
Division name	Department of Obstetrics and Gynecology
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	03-3762-4151
Email	masahiko.nakata@med.toho-u.ac.jp

Public contact
Name of contact person	Masahiko Nakata
Organization	Toho University Omori Medical Center
Division name	Department of Obstetrics and Gynecology
Address	6-11-1 Omorinishi, Ota-ku, Tokyo
TEL	03-3762-4151
Homepage URL
Email	masahiko.nakata@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	Toho University Omori Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東邦大学医療センター大森病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 25 Day
Anticipated trial start date	2018 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Analysis of data in clinical records

Management information
Registered date	2018 Year 01 Month 05 Day
Last modified on	2018 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035041