Combined Anesthesia for Labor and Maternal Temperature

NCT01078519 | Completed Phase 3 DMC

• 1 other identifier: NCT00992524
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pyrexia; Abdominal Delivery

Keywords

Fever; anesthesia; Labor

Outcome Measures

Primary Outcomes (1)

• Fever frequency

  We will measure the temperature each hour

  each hour

Secondary Outcomes (1)

• Incidence of c-section and instrumental delivery

  within the delivery

Study Arms (2)

Massages baths

NO INTERVENTION

doulas, massages and baths

Combined spinal-epidural anesthesia

ACTIVE COMPARATOR

local anesthetics in low doses with opioids

Drug: Combined epidural and spinal anesthesia

Interventions

Combined epidural and spinal anesthesia DRUG

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

Also known as: Local anesthetics, spinal opioides

Combined spinal-epidural anesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Maternal fever before randomization
• Antibiotics before randomization
• haemostatic disorders during pregnancy
• severe preeclâmpsia-eclampsia

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

MeSH Terms

Conditions

Fever

Interventions

Anesthesia, Spinal; Anesthetics, Local

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Flavia A Orange

  IMIP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 2, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 15, 2010

Record last verified: 2007-12