UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015745 |
|---|---|
| Receipt number | R000018325 |
| Scientific Title | Study on noninvasive stress measurement of mother and child at birth |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2018/03/21 19:38:29 |
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Basic information
Public title
Study on noninvasive stress measurement of mother and child at birth
Acronym
Dynamics of stress-related substances by saliva during delivery
Scientific Title
Study on noninvasive stress measurement of mother and child at birth
Scientific Title:Acronym
Dynamics of stress-related substances by saliva during delivery
Region
| Japan |
Condition
Condition
Delivery
Classification by specialty
| Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Find the way and challenges aid, and it is an object thereof to improve the assistance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of cortisol, oxytocin, amylase activity by saliva in the first part of labor, 2 hours after parturition, 2 days after parturition. Measurement of cortisol and oxytocin by umbilical cord blood.
Key secondary outcomes
Pality, duration of labor, duration of complaints and complaints at birth, delivery time, presence or absence of perineal region sutures, awareness of breast tightness on day 2 of delivery, presence of emotional tears till the second day of delivery.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
It measures the blood glucose level, lactic acid value and the hematocrit value in the umbilical cord blood.
Interventions/Control_2
Sampling the umbilical cord blood and maternal the maternal saliva (delivery before･delivery two hours after･delivery two days later).
Interventions/Control_3
The cortisol concentration and oxytocin concentrations were bioassay, to detect.
Interventions/Control_4
I investigate the fetal bradycardia in childbirth monitoring apparatus of labor just before 10 minutes.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women before, during and after delivery.
Key exclusion criteria
Cesarean section
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yaeko Inaba |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
Address
4-2-2, Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832
TEL
0745-54-1601
inabayaeko@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yaeko Inaba |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
Address
4-2-2, Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832
TEL
0745-54-1601
Homepage URL
inabayaeko@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Funaki maternity hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
ふなき助産院(大阪府) Funaki maternity hospital (Osaka prefecture)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Salivary cortisol saliva oxytocin, salivary amylase, umbilical cord blood cortisol umbilical cord blood oxytocin completed the assay.
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018325
| 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 |
