Combined Anesthesia for Labor and Maternal Temperature (feveranalg)

Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pyrexia; Abdominal Delivery
• Intervention / Treatment: Drug: Combined epidural and spinal anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fever frequency	We will measure the temperature each hour	each hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of c-section and instrumental delivery	Will measure the instrumental delivery when the CSA technique is used	within the delivery

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Investigators: Principal Investigator: Flavia A Orange, IMIP

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (ESTIMATE): March 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2010
• Last Update Submitted That Met QC Criteria: July 14, 2010
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: anesthesia; Fever; Labor
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: NCT00992524