NCT00326521

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

First QC Date

May 15, 2006

Last Update Submit

June 5, 2008

Conditions

Fever

Keywords

Pregnant WomenEpidural AnesthesiaFeverChorioamnionitisIntrauterine pressure catheterPregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Multiparous
  • Maternal age \< 18 years of age
  • External tocometer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

RECRUITING

UCI Medical Center

Orange, California, 92686, United States

RECRUITING

Related Publications (6)

  • Gibbs RS, Blanco JD, St Clair PJ, Castaneda YS. Quantitative bacteriology of amniotic fluid from women with clinical intraamniotic infection at term. J Infect Dis. 1982 Jan;145(1):1-8. doi: 10.1093/infdis/145.1.1.

    PMID: 7033397BACKGROUND

  • Lieberman E, O'donoghue C. Unintended effects of epidural analgesia during labor: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S31-68. doi: 10.1067/mob.2002.122522.

    PMID: 12011872BACKGROUND

  • Ramin SM, Gambling DR, Lucas MJ, Sharma SK, Sidawi JE, Leveno KJ. Randomized trial of epidural versus intravenous analgesia during labor. Obstet Gynecol. 1995 Nov;86(5):783-9. doi: 10.1016/0029-7844(95)00269-w.

    PMID: 7566849BACKGROUND

  • Yancey MK, Zhang J, Schwarz J, Dietrich CS 3rd, Klebanoff M. Labor epidural analgesia and intrapartum maternal hyperthermia. Obstet Gynecol. 2001 Nov;98(5 Pt 1):763-70. doi: 10.1016/s0029-7844(01)01537-x.

    PMID: 11704166BACKGROUND

  • Lieberman E, Lang JM, Frigoletto F Jr, Richardson DK, Ringer SA, Cohen A. Epidural analgesia, intrapartum fever, and neonatal sepsis evaluation. Pediatrics. 1997 Mar;99(3):415-9. doi: 10.1542/peds.99.3.415.

    PMID: 9041298BACKGROUND

  • Chen KT, Ringer S, Cohen AP, Lieberman E. The role of intrapartum fever in identifying asymptomatic term neonates with early-onset neonatal sepsis. J Perinatol. 2002 Dec;22(8):653-7. doi: 10.1038/sj.jp.7210818.

    PMID: 12478449BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Maternal serum, amniotic fluid, and umbilical cord blood

MeSH Terms

Conditions

FeverChorioamnionitis

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Michael P Nageotte, MD

    Memorial Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Preslicka, Rn

CONTACT

562-933-2755Cpreslicka@memorialcare.org

Michael P Nageotte, MD

CONTACT

562-933-2730mnageotte@memorialcare.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

October 1, 2006

Study Completion

May 1, 2009

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

US(2)