Combined Anesthesia for Labor and Maternal Temperature (feveranalg)

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01078519
First received: February 25, 2010
Last updated: July 14, 2010
Last verified: December 2007
  Purpose

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 Intervention Phase
Pyrexia
Abdominal Delivery
Drug: Combined epidural and spinal anesthesia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • Fever frequency [ Time Frame: each hour ] [ Designated as safety issue: Yes ]
    We will measure the temperature each hour


Secondary Outcome Measures:
  • Incidence of c-section and instrumental delivery [ Time Frame: within the delivery ] [ Designated as safety issue: Yes ]
    Will measure the instrumental delivery when the CSA technique is used


Enrollment: 70
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01078519

Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Principal Investigator: Flavia A Orange IMIP
  More Information

No publications provided

Responsible Party: Flavia Augusta de Orange, Instituto Materno infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01078519     History of Changes
Other Study ID Numbers: NCT00992524
Study First Received: February 25, 2010
Last Updated: July 14, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Fever
anesthesia
Labor

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014