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Combined Anesthesia for Labor and Maternal Temperature

Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01078519
Acronym
feveranalg
Enrollment
70
Registered
2010-03-02
Start date
2010-01-31
Completion date
2010-06-30
Last updated
2010-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Delivery, Pyrexia

Keywords

Fever, anesthesia, Labor

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.

Interventions

DRUGCombined 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

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Fever frequencyeach hourWe will measure the temperature each hour

Secondary

MeasureTime frameDescription
Incidence of c-section and instrumental deliverywithin the deliveryWill measure the instrumental delivery when the CSA technique is used

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026