Recruiting

Epidural Anesthesia

Sponsor:

MemorialCare

Code:

NCT00326521

Conditions

Fever

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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).

Conditions

Fever

Study ID

NCT00326521

Start date

Oct, 2006

Status verified date

Jun, 2008

Completion date

May, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Locations

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Principal Investigator:

Michael P Nageotte, MD

UCI Medical Center

Recruiting

Orange, California, United States, 92686

Contacts

Principal Investigator:

Deborah Wing, MD

More Information

Sponsor

MemorialCare

Last update posted

Jun 6, 2008

Last verified

Jun, 2008

Keywords

  • Pregnant Women
  • Epidural Anesthesia
  • Fever
  • Chorioamnionitis
  • Intrauterine pressure catheter
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MemorialCare on 2008-06-06.