NCT00879190

Brief Summary

Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 15, 2017

Completed
Last Updated

May 18, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

April 7, 2009

Results QC Date

October 31, 2016

Last Update Submit

April 18, 2018

Conditions

Chorioamnionitis

Outcome Measures

Primary Outcomes (1)

  • Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum

    Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum

    Up to 24 hours after delivery

Secondary Outcomes (2)

  • Composite Maternal Morbidity

    Up to 6 weeks after delivery

  • Neonatal Clinical Sepsis (Early Onset)

    Up to 6 weeks after delivery

Study Arms (2)

Unasyn (ampicillin/sulbactam)

ACTIVE COMPARATOR
Drug: Unasyn

Ampicillin/gentamicin

ACTIVE COMPARATOR
Drug: Ampicillin/gentamicin

Interventions

UnasynDRUG

Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.

Unasyn (ampicillin/sulbactam)
Ampicillin/gentamicinDRUG

Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.

Ampicillin/gentamicin

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women in labor or undergoing induction of labor
  • Greater than or equal to 18 years of age
  • Diagnosed with chorioamnionitis as defined by maternal temperature \> or = 38.0 degrees Centigrade plus at least one of the following: maternal tachycardia (heart rate \>110), fetal tachycardia (fetal heart rate baseline \>160), purulent amniotic fluid, uterine tenderness.

You may not qualify if:

  • Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
  • Having received antibiotics for the treatment of preterm premature rupture of membranes or other condition within the last 7 days
  • Acute or chronic renal disease or insufficiency (creatinine \>1.0)
  • Hearing loss
  • Major fetal congenital anomalies or intrauterine fetal demise
  • Neutropenia
  • HIV
  • Myasthenia gravis or other neuromuscular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Greenberg, Mara et al. Comparison of ampicillin/sulbactam versus ampicillin/gentamicin for treatment of intrapartum chorioamnionitis: a randomized controlled trial. American Journal of Obstetrics & Gynecology , Volume 212 , Issue 1 , S145

    RESULT

Related Links

MeSH Terms

Conditions

Chorioamnionitis

Interventions

sultamicillinAmpicillinGentamicins

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Penicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Anna Girsen, Manager of Maternal-Fetal Medicine Research Operations
Organization
Stanford University, Department of Obstetrics & Gynecology
agirsen@stanford.edu
(650) 725-0499

Study Officials

  • Natali Aziz, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 18, 2018

Results First Posted

March 15, 2017

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)