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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
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyrexia focused on measuring Fever, anesthesia, Labor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 25, 2010
    Last Updated
    July 14, 2010
    Sponsor
    Instituto Materno Infantil Prof. Fernando Figueira
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    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

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    Combined Anesthesia for Labor and Maternal Temperature

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