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Combined Anesthesia for Labor and Maternal Temperature (feveranalg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078519
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : July 15, 2010
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira

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.

Condition or disease Intervention/treatment Phase
Pyrexia Abdominal Delivery Drug: Combined epidural and spinal anesthesia Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
No Intervention: Massages baths
doulas, massages and baths
Active Comparator: Combined spinal-epidural anesthesia
local anesthetics in low doses with opioids
Drug: Combined epidural and spinal anesthesia
Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids
Other Names:
  • Local anesthetics
  • spinal opioides

Primary Outcome Measures :
  1. Fever frequency [ Time Frame: each hour ]
    We will measure the temperature each hour

Secondary Outcome Measures :
  1. Incidence of c-section and instrumental delivery [ Time Frame: within the delivery ]
    Will measure the instrumental delivery when the CSA technique is used

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01078519

Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
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Principal Investigator: Flavia A Orange IMIP
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Responsible Party: Flavia Augusta de Orange, Instituto Materno infantil Prof. Fernando Figueira Identifier: NCT01078519    
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: December 2007
Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents