Trial record 14 of 227 for:    Open Studies | "Fever"

Evaluation of Fever Occurring in Labor in Patients Receiving Epidural Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by MemorialCare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00326521
First received: May 15, 2006
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

Briefly, the investigators propose to evaluate nulliparous (first time mothers) patients beyond 36 0/7 weeks' gestation in active labor who already have received epidural anesthesia and have an intrauterine pressure catheter (IUPC) in place. Any patient who then develops a single temperature elevation of > 38 degrees will be eligible for inclusion and consented for the study. Maternal blood will be drawn immediately, one hour later and at delivery. Amniotic fluid will be aspirated from the pressure catheter; the first 1-2 cc will be discarded and the remainder will be evaluated for gram stain, culture, glucose level, interleukin-6 (IL-6), and proteomics. All placentas will be sent for routine pathologic examination. Cord blood will be obtained at birth for routine studies. Both maternal and cord blood will be sent for proteomic evaluation (defined). The patients with amniotic fluid that has a positive gram stain and culture will be defined as the infected group, and the patients with amniotic fluid that has a negative gram stain and culture will be defined as the uninfected group. Differences in clinical presentation and laboratory assessments, including proteomics, will be compared between the two groups to determine if there are any markers that might prove to be useful in distinguishing between these two entities (epidural fever with and without actual infection).


Condition Phase
Fever
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Intrapartum Fever in Patients Receiving Epidural Anesthesia

Resource links provided by NLM:


Further study details as provided by MemorialCare:

Biospecimen Retention:   Samples With DNA

Maternal serum, amniotic fluid, and umbilical cord blood


Estimated Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: May 2009
Detailed Description:

Historically the diagnosis of chorioamnionitis (an infection of the membranes surrounding the fetus) for patients in labor has been made on the basis of multiple clinical variables such as maternal fever, fetal tachycardia, uterine tenderness, or foul smelling vaginal discharge. The diagnosis also takes into account a clinical picture consistent with risk factors such as prolonged labor and prolonged rupture of membranes. Since most of these findings are not specific, chorioamnionitis becomes the diagnosis of exclusion unless there is another explanation for the fever. Randomized studies have clearly shown that maternal antibiotics and neonatal septic work-ups are indicated once the diagnosis of chorioamnionitis has been made. Neonatal sepsis is a severe infection of the blood stream. Such policies have important implications for health care providers, on the impact of medical costs, and on the duration of hospital stay. This becomes especially true for the newborn that is transferred to the neonatal intensive care unit (NICU) for sepsis evaluation. Often times, these newborns are prophylactically treated with antibiotics based on the suspicion of an infection, while waiting for finalized blood culture results. Since newborn sepsis is such a difficult diagnosis to make, many more newborns are treated than actually have the disease and the length of their hospital stay may be significantly increased.

Over the past 15 years, both observational and randomized trials have observed an increase in maternal fever associated with epidural anesthesia in labor. These trials have shown increased ranges from 10 - 15% over baseline rates and an increased relative risk of 1.5 to 15 fold, and even up to 70 fold in one study, over the rates seen in women not receiving epidural anesthesia. After correcting for duration of labor and other confounding variables, these increases remained present. Since epidural fever is virtually impossible to distinguish from chorioamnionitis-related fever, these women are almost all treated with antibiotics and given the diagnosis of infection. This approach also has tremendous impact on the evaluation and care of the newborn. Two specific studies evaluated this impact on the neonate. Lieberman found that babies of mothers given epidural anesthesia were more likely to be evaluated for sepsis (34 vs. 9%) and treated with antibiotics (15 vs. 4%). Similarly, Philips found the same increase (25 vs. 16% and 19 vs. 11%). Both studies had very low rates of confirmed neonatal sepsis. On a national basis, the cost of this confusion nationally is tremendous.

There is one known way to distinguish between true chorioamnionitis in labor and non-infectious fever due to the epidural anesthesia. Gibbs and colleagues found that amniotic fluid aspirated from an intrauterine pressure catheter, a device commonly utilized for monitoring contractions in labor, could be used to accurately make the diagnosis of infection using gram stain and culture. More recently, many papers have shown that low glucose levels and elevated IL-6 in amniotic fluid were also accurate tests for infection. While these markers could in theory be used for distinguishing between epidural fever and true chorioamnionitis, most patients do not require such a device and this approach would not likely gain widespread favor. Alternatively, however, this approach could be used as a research tool in women who already have such a catheter in place to determine if there are additional non-invasive clinical or laboratory markers to distinguish one from the other.

Recently proteomic assessment has become an extremely effective tool in determining if there are certain markers for various diseases. Proteomics is the determination of the structure, function, and expression of all of the corresponding proteins that are encoded within the genome structure. It can also be defined as the "fingerprint" of a disease process. It involves running tandem mass spectometry on the fluid of interest. Such an approach could be extremely valuable both in determining whether the mother actually has chorioamnionitis and, if so, whether there are better markers for neonatal sepsis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women >18 years of age that present to labor and delivery and are in active labor.

Criteria

Inclusion Criteria:

  • Nulliparous
  • Maternal age > 18 years of age
  • Estimated gestational age (EGA) > 36 0/7 weeks
  • Active labor (> 4 cm dilated)
  • Epidural anesthesia
  • IUPC in place prior to development of fever
  • Temperature of > 38 degrees
  • Consents to study

Exclusion Criteria:

  • Multiparous
  • Maternal age < 18 years of age
  • External tocometer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326521

Contacts
Contact: Christine Preslicka, Rn 562-933-2755 Cpreslicka@memorialcare.org
Contact: Michael P Nageotte, MD 562-933-2730 mnageotte@memorialcare.org

Locations
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Christine Preslicka, RN    562-933-2755    cpreslicka@memorialcare.org   
Contact: Michael P Nageotte, MD    562-933-2730    mnageotte@memorialcare.org   
Principal Investigator: Michael P Nageotte, MD         
Sub-Investigator: Kim C Winovitch, MD         
UCI Medical Center Recruiting
Orange, California, United States, 92686
Contact: Pam Rumney, RN    714-456-5967    prumney@uci.edu   
Contact: Deborah Wing, MD    714-456-5967    dwing@uci.edu   
Principal Investigator: Deborah Wing, MD         
Sub-Investigator: Kim C Winovitch, MD         
Sponsors and Collaborators
MemorialCare
Investigators
Principal Investigator: Michael P Nageotte, MD Memorial Care
  More Information

Publications:
Responsible Party: Christine Preslicka, Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine
ClinicalTrials.gov Identifier: NCT00326521     History of Changes
Other Study ID Numbers: 297-05
Study First Received: May 15, 2006
Last Updated: June 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Pregnant Women
Epidural Anesthesia
Fever
Chorioamnionitis
Intrauterine pressure catheter
Pregnancy

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014