Combined Anesthesia for Labor and Maternal Temperature (feveranalg)
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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 |
- Fever frequency [ Time Frame: each hour ] [ Designated as safety issue: Yes ]We will measure the temperature each hour
- 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:
|
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 |
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
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 May 19, 2013