UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039981 |
|---|---|
| Receipt number | R000045584 |
| Scientific Title | Delivery outcomes of emergent cesarean section candidates: a prospective data collection |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2026/09/06 21:28:50 |
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Basic information
Public title
Delivery outcomes of emergent cesarean section candidates
Acronym
Delivery outcomes of emergent cesarean section candidates
Scientific Title
Delivery outcomes of emergent cesarean section candidates: a prospective data collection
Scientific Title:Acronym
Delivery outcomes of emergent cesarean section candidates
Region
| Japan |
Condition
Condition
Pregnancy and delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the risk of developing emergent cesarean section among parturients considered candidates for emergent cesarean section.
Basic objectives2
Others
Basic objectives -Others
Epidemiological research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The risk of developing emergent cesarean section in parturients considered candidates for emergent cesarean section.
Key secondary outcomes
Base
Study type
Observational
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
Female
Key inclusion criteria
Parturients hospitalized in Teine Keijinkai Hospital, who were considered candidates for emergent cesarean section.
Key exclusion criteria
Patients who refused to participate in the study.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishihara |
Organization
Teine Keijinkai Hospital
Division name
Department of anesthesiology
Zip code
006-8555
Address
Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
ishihara-sat@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ishihara |
Organization
Teine Keijinkai Hospital
Division name
Departmedn of anesthesiology
Zip code
006-8555
Address
Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
TEL
011-681-8111
Homepage URL
ishihara-sat@keijinkai.or.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Teine Keijinkai Hospital
Address
Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
Tel
011-681-8111
tkh-rinriml@keijinkai.or.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
手稲渓仁会病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.micenavi.jp/jsashibu2026/search/detail_program/id:291
Publication of results
Published
Result
URL related to results and publications
https://www.micenavi.jp/jsashibu2026/search/detail_program/id:291
Number of participants that the trial has enrolled
141
Results
Among the 75 women in the double setup group, 53 delivered within 6 hours, and 66 delivered within 12 hours.
The predefined event, an emergency cesarean section requiring delivery within 1 hour, occurred in 22 women.
Results date posted
| 2026 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 141 women received consultation during the study period.
The median maternal age at delivery among all 141 cases was 33 years, and the median gestational age was 38 weeks, 98 women were nulliparous.
When limited to the 75 cases managed with a double setup, the median maternal age, median gestational age, and proportion of nulliparous women were 32 years, 39 weeks, and 58 women, respectively, demonstrating a broadly similar pattern.
The median observation period for the 75 double setup cases was 3 hours and 30 minutes.
Participant flow
Among the 141 participants, 75 women undergoing the double setup procedure were observed until the time of delivery.
Among the 66 women who received prelabor consultation, 4 discontinued observation before the onset of labor.
Adverse events
Adverse events were not observed
Outcome measures
An emergency cesarean section requiring delivery within 1 hour was defined as the event of interest.
Among the 75 women managed with a double setup, 22 cases (29%) experienced such an event.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 09 | Month | 05 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 05 | Day |
Other
Other related information
Parturients who were hospitalized in Teine Keijinkai Hospital and considered candidates of emergent cesarean section are enrolled. Their delivery outcome data (i.e. emergent cesarean section or other modalities of delivery) are prospectively collected, to clarify the risk of developing emergent cesarean section.
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045584
