Clinical trial NCT01078519: Combined Anesthesia for Labor and Maternal Temperature
Official title: Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pyrexia
Abdominal Delivery
Keywords: Fever
anesthesia
Labor
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fever frequency
timeFrame: each hour
Secondary outcomes:
measure: Incidence of c-section and instrumental delivery
timeFrame: within the delivery
Other outcomes:
Locations:
Study officials:
affiliation: IMIP
name: Flavia A Orange
role: PRINCIPAL_INVESTIGATOR
References: