UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050609 |
|---|---|
| Receipt number | R000057646 |
| Scientific Title | Factors affecting occurrence of fetal bradycardia during neuraxial labor analgesia |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/16 13:38:38 |
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Basic information
Public title
Factors affecting occurrence of fetal bradycardia during neuraxial labor analgesia
Acronym
Factors affecting occurrence of fetal bradycardia during neuraxial labor analgesia
Scientific Title
Factors affecting occurrence of fetal bradycardia during neuraxial labor analgesia
Scientific Title:Acronym
Factors affecting occurrence of fetal bradycardia during neuraxial labor analgesia
Region
| Japan |
Condition
Condition
fetal bradycardia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to identify risk factors for fatal bradycardia during neuraxial labor analgesia.
Basic objectives2
Others
Basic objectives -Others
Epidemiologic study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of fatal bradycardia during 30 minutes after application of neuraxial labor analgesia to parturient
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
| 16 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Neuraxial labor analgesia by anesthesiologists from January 2022 to December 2022
Key exclusion criteria
None
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University Graduate School of Medicine
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-7321
shigekazu.sugino.d3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University Graduate School of Medicine
Division name
Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-7321
Homepage URL
shigekazu.sugino.d3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Shigekazu Sugino
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aiiku Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi, JAPAN
Tel
+81-22-717-8007
med-kenkyo@grp.tohoku.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
愛育病院(東京都)，東北大学麻酔科(宮城県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
1708
Results
The overall occurrence of fetal bradycardia was 10% (171/1708 patients). We identified 3 risk factors: primigravid women had twice the odds of fetal bradycardia than parous women (p = 0.007); the risk factors for parous women were cervical dilatation of at least 5 cm and pain intensity of at least 8 on the numeric rating scale.
Results date posted
| 2024 | Year | 03 | Month | 16 | Day |
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 30 | Day |
Other
Other related information
Experimental Design: a retrospective observational study
Participants: parturients who received neuraxial labor analgesia by anesthesiologists at Aiiku Hospital
Measurements: age, height, weight, ASA-PS classification, race, nulliparous, pregnancy-induced hypertension, fatal bradycardia prior to neuraxial labor analgesia, labor onset, weeks of pregnancy, cervical dilatation, pain scores before and after neuraxial labor analgesia, AFI, oxytocin administration, presence of occiput posterior, type of anesthesia, the total amount of epidural test dose, a total dose of drugs in the spinal component of CSEA, total dose of nitroglycerin, total dose of vasopressor, occurrence of maternal hypotension after neuraxial labor analgesia, the incidence of Caesarian delivery, Apgar scores, and occurrence of fatal bradycardia after neuraxial labor analgesia
Management information
Registered date
| 2023 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057646
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