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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001193
Receipt No. R000001458
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 2008/06/17
Last modified on 2008/06/17

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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 occurring after labor analgesia
Classification by specialty
Obsterics 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 standard 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 bupivacaine 12,5mg 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 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 Av Dr Eneas de Carvalho Aguiar, 255, 10 andar
TEL 551130696209
Email

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 551130696209
Homepage URL http://www.hcnet.usp.br/ob/
Email rossana.francisco@hcnet.usp.br

Sponsor
Institute Department of Obstetrics and Gynecology -University of Sao Paulo - Brazil
Institute
Department

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
Email

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 06 Month 17 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 17 Day
Last modified on
2008 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001458

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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