PyrexiaPhase 3feveranalgNCT01078519
Combined Anesthesia for Labor and Maternal Temperature
A Phase 3 study testing Combined epidural and spinal anesthesia in people with Pyrexia and Abdominal Delivery, run by Instituto Materno Infantil Prof. Fernando Figueira.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pyrexia, Abdominal Delivery
- What is being tested?
- Combined epidural and spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Maternal fever before randomization
- Antibiotics before randomization
- haemostatic disorders during pregnancy
- severe preeclâmpsia-eclampsia
About this study
Official title: Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial
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.
Read the 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
- Being tested
- Combined epidural and spinal anesthesia
- Keywords
- Fever, anesthesia, Labor
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined epidural and spinal anesthesiaDrug
Also called Local anesthetics, spinal opioides
Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids
| Study group | Role | What they receive |
|---|---|---|
| Massages baths | No intervention | doulas, massages and baths |
| Combined spinal-epidural anesthesia | Active comparator | local anesthetics in low doses with opioids Receives: Drug: Combined epidural and spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever frequency
We will measure the temperature each hour
Measured: each hour
Secondary outcomes (1)
Incidence of c-section and instrumental delivery
Will measure the instrumental delivery when the CSA technique is used
Measured: within the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyrexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Investigators
- Flavia A Orange, Principal investigator, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078519
- Sponsor's protocol ID
- NCT00992524
- Acronym
- feveranalg
- Status last verified
- Dec 2007
- First submitted
- 25 Feb 2010
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Spinal and Epidural Anesthesia and Maternal Intrapartum Temperature During Vaginal Delivery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01078519
- Acronym / sponsor ID
- feveranalg / NCT00992524
- Conditions
- Pyrexia, Abdominal Delivery
- Keywords
- Fever, anesthesia, Labor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massages baths | No intervention | –doulas, massages and baths |
| Combined spinal-epidural anesthesia | Active comparator | Drug: Combined epidural and spinal anesthesialocal anesthetics in low doses with opioids |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Maternal fever before randomization
- Antibiotics before randomization
- haemostatic disorders during pregnancy
- severe preeclâmpsia-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined epidural and spinal anesthesiaAlso: Local anesthetics, spinal opioidesObstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids | Drug | Combined spinal-epidural anesthesia |
Primary outcome
Fever frequency
Time frame: each hour
We will measure the temperature each hour
1 secondary outcome
Incidence of c-section and instrumental delivery
Time frame: within the delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia A Orange principal investigator
IMIP
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combined epidural and spinal anesthesia in people with Pyrexia and Abdominal Delivery, run by Instituto Materno Infantil Prof. Fernando Figueira.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever frequency (time frame: each hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2010.