FeverEarly Phase 1NCT02212210
Maternal Epidural Steroids and Hyperthemia
A Early Phase 1 study testing Methylprednisolone and Normal saline in people with Fever and Labor Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fever, Labor Pain, Complication of Anesthesia During Pregnancy, Unspecified
- What is being tested?
- Methylprednisolone and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2015
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparity
- Age>=18
- Patient requests epidural analgesia
- GA >= 37 weeks
Who cannot join
- No prenatal care
- Temperature >99.4 at decision for epidural placement
- Cervical dilation >4cm
- Diabetes (pre-gestational or gestational)
- Autoimmune condition
- Pre-eclampsia
Show all 16Show fewer
- Maternal heart disease
- Current steroid use
- Active infection (bacterial or viral)
- Wet Tap (CSF on placement of epidural)
- Pre-gestational diabetes
- Known systemic infection (bacterial, viral, fungal or tubercular)
- Known allergy to steroids
- Heart failure
- Hypertensive crisis
- History of active epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.
Read the detailed description
The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.
- Being tested
- Methylprednisolone, Normal saline
- Medical subject headings
- Fever, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called DEPO-MEDROL
Normal salineDrug
Also called Saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | 1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline Receives: Drug: Methylprednisolone |
| Normal saline | Placebo comparator | 2cc preservative free normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maternal fever
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
Measured: delivery
Secondary outcomes (1)
Rate of funisitis
Cord segment will be collected at time of delivery and fetal end identified and sent to pathologist for evidence of funisitis, grade and stage.
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionOct 2015
Why it stopped: PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher G. Goodier, Medical University of South Carolina
- Investigators
- Christopher G Goodier, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212210
- Sponsor's protocol ID
- Goodier_Epidural_Steroids
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation
- ClinicalTrials.gov ID
- NCT02212210
- Acronym / sponsor ID
- Goodier_Epidural_Steroids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Aug 2014 (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.
The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.
Detailed description
The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone1cc of 80mg methylprednisolone to be diluted with 1cc preservative free normal saline |
| Normal saline | Placebo comparator | Drug: Normal saline2cc preservative free normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nulliparity
- Age>=18
- Patient requests epidural analgesia
- GA >= 37 weeks
Key exclusion criteria (16 listed)
- No prenatal care
- Temperature >99.4 at decision for epidural placement
- Cervical dilation >4cm
- Diabetes (pre-gestational or gestational)
- Autoimmune condition
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 |
|---|---|---|
| MethylprednisoloneAlso: DEPO-MEDROL | Drug | Methylprednisolone |
| Normal salineAlso: Saline placebo | Drug | Normal saline |
Primary outcome
Rate of maternal fever
Time frame: delivery
Oral maternal temperature will be collected hourly starting at epidural placement. Temperature will be recorded until delivery.
1 secondary outcome
Rate of funisitis
Time frame: delivery
Results and safety
The study was stopped early (reason given: PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Christopher G Goodier, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylprednisolone and Normal saline in people with Fever and Labor Pain, run by Medical University of South Carolina at 1 site in United States.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed). Results are not available in the source record.
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?
Rate of maternal fever (time frame: delivery). 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 29 Aug 2017.