Intrapartum Fever: Antibiotics Versus no Treatment

NCT03168178 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 91955
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether antibiotics can be safely avoided in women who develop a fever during labor. Because investigators have no accurate tests to determine whether women who develop fever during labor have intra-amniotic infection, antibiotics are often used to prevent spread of infection to the fetus.

Conditions

Chorioamnionitis; Intrapartum Fever; Intra-amniotic Infection

Outcome Measures

Primary Outcomes (1)

• Neonatal antibiotic treatment as recommended by the EONS (Early Onset Neonatal Sepsis) calculator.

  All newborns will have a screening assessment including physical exam and vital signs, and this data along with maternal and delivery data is entered into the Kaiser Permanente Early Onset Neonatal Sepsis (EONS) calculator. The EONS calculator estimates the risk of sepsis and recommends observation, additional evaluation, or empiric antibiotic treatment.

  Within 2 hours of delivery

Secondary Outcomes (7)

• Positive blood culture

  Up to 4 days after birth

• Need for NICU admission

  Up to 4 weeks after birth

• Newborn length of stay

  Up to 4 weeks after birth

• Maternal endometritis

  Up to 4 weeks after birth

• Maternal length of stay

  Up to 4 weeks after birth

Study Arms (2)

Standard Antibiotic Treatment

ACTIVE COMPARATOR

Standard antibiotic treatment provided to patient. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.

Drug: Standard Antibiotic Treatment

No Antibiotic Treatment

EXPERIMENTAL

No Antibiotic treatment given. Placenta submitted for pathologic exam. Maternal and neonatal outcomes collected.

Other: No Antibiotic Treatment

Interventions

Standard Antibiotic Treatment DRUG

Participants randomized to this intervention will receive standard antibiotic treatment. The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes

Standard Antibiotic Treatment

No Antibiotic Treatment OTHER

Participant randomized to this arm of the study will not receive antibiotics. The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes

No Antibiotic Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 34-42 weeks gestation
• Singleton fetus
• Admitted for labor management \& develops a fever of 100.4 F or greater

You may not qualify if:

• Known fetal anomaly
• Other indication for intrapartum antibiotics (endocarditis prophylaxis, other known maternal infection)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, 84132, United States

Location

Related Publications (10)

• Smulian JC, Bhandari V, Vintzileos AM, Shen-Schwarz S, Quashie C, Lai-Lin YL, Ananth CV. Intrapartum fever at term: serum and histologic markers of inflammation. Am J Obstet Gynecol. 2003 Jan;188(1):269-74. doi: 10.1067/mob.2003.11.

  PMID: 12548228 BACKGROUND

• Smulian JC, Shen-Schwarz S, Vintzileos AM, Lake MF, Ananth CV. Clinical chorioamnionitis and histologic placental inflammation. Obstet Gynecol. 1999 Dec;94(6):1000-5. doi: 10.1016/s0029-7844(99)00416-0.

  PMID: 10576190 BACKGROUND

• Roberts DJ, Celi AC, Riley LE, Onderdonk AB, Boyd TK, Johnson LC, Lieberman E. Acute histologic chorioamnionitis at term: nearly always noninfectious. PLoS One. 2012;7(3):e31819. doi: 10.1371/journal.pone.0031819. Epub 2012 Mar 7.

  PMID: 22412842 BACKGROUND

• Taylor JA, Opel DJ. Choriophobia: a 1-act play. Pediatrics. 2012 Aug;130(2):342-6. doi: 10.1542/peds.2012-0106. Epub 2012 Jul 9.

  PMID: 22778303 BACKGROUND

• Escobar GJ, Puopolo KM, Wi S, Turk BJ, Kuzniewicz MW, Walsh EM, Newman TB, Zupancic J, Lieberman E, Draper D. Stratification of risk of early-onset sepsis in newborns >/= 34 weeks' gestation. Pediatrics. 2014 Jan;133(1):30-6. doi: 10.1542/peds.2013-1689. Epub 2013 Dec 23.

  PMID: 24366992 BACKGROUND

• Cuna A, Hakima L, Tseng YA, Fornier B, Islam S, Quintos-Alagheband ML, Khullar P, Weinberger B, Hanna N. Clinical dilemma of positive histologic chorioamnionitis in term newborn. Front Pediatr. 2014 Apr 4;2:27. doi: 10.3389/fped.2014.00027. eCollection 2014.

  PMID: 24772410 BACKGROUND

• Evers AC, Nijhuis L, Koster MP, Bont LJ, Visser GH. Intrapartum fever at term: diagnostic markers to individualize the risk of fetal infection: a review. Obstet Gynecol Surv. 2012 Mar;67(3):187-200. doi: 10.1097/OGX.0b013e31824bb5f1.

  PMID: 22901952 BACKGROUND

• Buhimschi IA, Christner R, Buhimschi CS. Proteomic biomarker analysis of amniotic fluid for identification of intra-amniotic inflammation. BJOG. 2005 Feb;112(2):173-81. doi: 10.1111/j.1471-0528.2004.00340.x.

  PMID: 15663581 BACKGROUND

• Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.

  PMID: 21518717 BACKGROUND

• Newman TB, Puopolo KM, Wi S, Draper D, Escobar GJ. Interpreting complete blood counts soon after birth in newborns at risk for sepsis. Pediatrics. 2010 Nov;126(5):903-9. doi: 10.1542/peds.2010-0935. Epub 2010 Oct 25.

  PMID: 20974782 BACKGROUND

MeSH Terms

Conditions

Chorioamnionitis

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Heather Campbell, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Low risk women will be randomized to standard antibiotic treatment versus no antiobiotics.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 30, 2017
• Study Start: June 8, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)