UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001186 |
|---|---|
| Receipt number | R000001451 |
| Scientific Title | Elevation of uterine basal tone after combined spinal epidural or epidural labor analgesia and its association with fetal heart rate abnormalities: a randomized double-blind study. |
| Date of disclosure of the study information | 2008/07/01 |
| Last modified on | 2008/06/13 11:57:14 |
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Basic information
Public title
Elevation of uterine basal tone after combined spinal epidural or epidural labor analgesia and its association with fetal heart rate abnormalities: a randomized double-blind study.
Acronym
Uterine hyperactivity and fetal heart rate abnormalities after combined spinal epidural or epidural analgesia
Scientific Title
Elevation of uterine basal tone after combined spinal epidural or epidural labor analgesia and its association with fetal heart rate abnormalities: a randomized double-blind study.
Scientific Title:Acronym
Uterine hyperactivity and fetal heart rate abnormalities after combined spinal epidural or epidural analgesia
Region
| South America |
Condition
Condition
fetal heart rate abnormalities and elevation of the uterine basal tone occurring after labor analgesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between elevation of uterine basal tone and nonreassuring fetal heart rate tracings after induction of labor analgesia with combined spinal epidural or epidural technique.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of elevation of uterine basal tone associated with nonreassuring fetal rate tracings after labor analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
combined spinal epidural analgesia with initial intrahecal injection of bupivacaine 2,5 mg with 2,5 mcg sufentanil
Interventions/Control_2
epidural analgesia with initial epidural injection of 12,5 mg bupivacaine with 10 mcg sufentanil
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
| 18 | years-old | < |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
laboring patients in active phase of labor with cervical dilatation between 3 and 7 cm, who asked for labor analgesia
Key exclusion criteria
contraindications to internal monitoring of uterine contractions,
contraindications to regional analgesia,
previous use of opiates for pain relief during labour
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Karen Cristine Abrao |
Organization
School of Medicine, University of Sao Paulo , Sao Paulo, Brazil
Division name
Department of Obstetrics and Gynecology
Zip code
Address
255, Dr Eneas de Carvalho Aguiar St, 255, 10th floor
TEL
55-11-30696445
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rossana Pulcineli Vieira Francisco |
Organization
School of Medicine, University of Sao Paulo , Sao Paulo, Brazil
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Av Dr Eneas de Carvalho Aguiar, 255, 10 andar
TEL
55-11-30696445
Homepage URL
http://www.hcnet.usp.br/ob/
rossana.francisco@hcnet.usp.br
Sponsor or person
Institute
Department of Obstetrics and Gynecology, School of Medicine, University of Sao Paulo - Brazil
Institute
Department
Personal name
Funding Source
Organization
CAPES - Coordenacao de aperfeicoamento de pessoal de nivel superior
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Brazil
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | 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
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
Completed
Date of protocol fixation
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 13 | Day |
Last modified on
| 2008 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001451
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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