Combined Anesthesia for Labor and Maternal Temperature

Phase 3

Completed

• Conditions: Pyrexia; Abdominal Delivery
• Interventions: Drug: Combined epidural and spinal anesthesia

• Registration Number: NCT01078519
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2007-12
• Study Start: 2010-01
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combined spinal-epidural anesthesia	Combined epidural and spinal anesthesia	local anesthetics in low doses with opioids

Primary Outcome Measures

Name	Time	Method
Fever frequency	each hour	We will measure the temperature each hour

Secondary Outcome Measures

Name	Time	Method
Incidence of c-section and instrumental delivery	within the delivery	Will measure the instrumental delivery when the CSA technique is used