Combined Anesthesia for Labor and Maternal Temperature (feveranalg)
Primary Purpose
Pyrexia, Abdominal Delivery
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combined epidural and spinal anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Pyrexia focused on measuring Fever, anesthesia, Labor
Eligibility Criteria
Inclusion Criteria:
- singleton pregnancies
- babies were presenting head first
- were expecting a vaginal delivery single fetal
- gestational age up to 37 weeks
- cervix length between 3-6 cm
Exclusion Criteria:
- Maternal fever before randomization
- Antibiotics before randomization
- haemostatic disorders during pregnancy
- severe preeclâmpsia-eclampsia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Massages baths
Combined spinal-epidural anesthesia
Arm Description
doulas, massages and baths
local anesthetics in low doses with opioids
Outcomes
Primary Outcome Measures
Fever frequency
We will measure the temperature each hour
Secondary Outcome Measures
Incidence of c-section and instrumental delivery
Will measure the instrumental delivery when the CSA technique is used
Full Information
NCT ID
NCT01078519
First Posted
February 25, 2010
Last Updated
July 14, 2010
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
1. Study Identification
Unique Protocol Identification Number
NCT01078519
Brief Title
Combined Anesthesia for Labor and Maternal Temperature
Acronym
feveranalg
Official Title
Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Maternal intra-partum fever commonly complicates the process of labour. Its occurrence is often regarded as being synonymous with the presence of chorioamnionitis. This inevitably results in the administration of antibiotics to the affected mother. Review of the literature however suggests that this approach is not always appropriate. Non-infective causes of this condition that are often overlooked include the use of epidural analgesia for pain relief, normal thermal physiological changes in women not using any form of analgesia and delivery in an overheated room. Women with certain risk factors such as nulliparity and a long latent phase of labour are also more prone to developing maternal intra-partum fever. Irrespective of its aetiology, maternal intra-partum fever carries risks both for the mother and her unborn child. Putting more thought into the care of these patients will go a long way in reducing the maternal and neonatal morbidity associated with this complication.The combined spinal-epidural (CSE) technique has been introduced in an attempt to reduce these adverse effects. CSE is believed to during labour provide more rapid onset of analgesia than epidural analgesia, The incidence of fever is significantly lower with CSE technique.
Detailed Description
The objective this study is determine the fever maternal incidence with CSE technique for labor analgesia.
METHODS: a randomized open clinical trial will be conducted involving Seventy healthy, term, nulliparous women in spontaneous labor were assigned to either CSE technique or non pharmacologic analgesia for labor.these patients will be randomly assigned to receive or not CSE technique for labor analgesia. Outcomes analysis wiil include maternal fever, pain intensity measured by visual analog scale, labor duration, c-section and instrumental delivery. statical analysis will performed using Mann-Whitney and Fisher" exact test 5% level of significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyrexia, Abdominal Delivery
Keywords
Fever, anesthesia, Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massages baths
Arm Type
No Intervention
Arm Description
doulas, massages and baths
Arm Title
Combined spinal-epidural anesthesia
Arm Type
Active Comparator
Arm Description
local anesthetics in low doses with opioids
Intervention Type
Drug
Intervention Name(s)
Combined epidural and spinal anesthesia
Other Intervention Name(s)
Local anesthetics, spinal opioides
Intervention Description
Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids
Primary Outcome Measure Information:
Title
Fever frequency
Description
We will measure the temperature each hour
Time Frame
each hour
Secondary Outcome Measure Information:
Title
Incidence of c-section and instrumental delivery
Description
Will measure the instrumental delivery when the CSA technique is used
Time Frame
within the delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
singleton pregnancies
babies were presenting head first
were expecting a vaginal delivery single fetal
gestational age up to 37 weeks
cervix length between 3-6 cm
Exclusion Criteria:
Maternal fever before randomization
Antibiotics before randomization
haemostatic disorders during pregnancy
severe preeclâmpsia-eclampsia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia A Orange
Organizational Affiliation
IMIP
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combined Anesthesia for Labor and Maternal Temperature
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