Combined Anesthesia for Labor and Maternal Temperature

NCT ID: NCT01078519

Last Updated: 2010-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Pyrexia; Abdominal Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Massages baths

doulas, massages and baths

Group Type: NO_INTERVENTION

No interventions assigned to this group

Combined spinal-epidural anesthesia

local anesthetics in low doses with opioids

Group Type: ACTIVE_COMPARATOR

Combined epidural and spinal anesthesia

Intervention Type: DRUG

Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Local anesthetics; spinal opioides

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Instituto Materno infantil Prof. Fernando Figueira

Principal Investigators

Flavia A Orange

Role: PRINCIPAL_INVESTIGATOR

IMIP

Other Identifiers

NCT00992524

Identifier Type: -

Identifier Source: org_study_id