We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00879190
Recruitment Status : Active, not recruiting
First Posted : April 9, 2009
Results First Posted : March 15, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chorioamnionitis Drug: Unasyn Drug: Ampicillin/gentamicin Phase 2 Phase 3

Detailed Description:
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine intrapartum treatment of Group B streptococcus (GBS) colonization using ampicillin. When a participating patient is diagnosed with chorioamnionitis, she will be randomized in a blinded fashion to Arm 1 (Unasyn) or Arm 2 (ampicillin/gentamicin). She will be treated as per standard of care with tylenol, intravenous fluids, and her labor managed per physician discretion. From the time of diagnosis of chorioamnionitis until determination of treatment success or failure in the postpartum period, the patient will receive intravenous antibiotics per the protocol arm to which they have been assigned. If a patient has already been receiving ampicillin for GBS, the ampicillin will be discontinued when the study drugs are initiated. In arm 1, the study drugs will consist of Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours. In arm 2, the study drugs will consist of gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2gm intravenously every 6 hours. For all patients, clindamycin will be given intravenously at the time of clamping of the umbilical cord in the event of a cesarean delivery, and continued as part of the antibiotic regimen as per standard of care for cesarean section in the setting of chorioamnionitis. With the exception of the saline placebo doses, both the Unasyn regimen and the ampicillin/gentamicin regimen are efficacious and widely utilized regimens for the treatment of intrapartum chorioamnionitis, and do not represent a deviation from standard of care. After delivery, if the patient experiences a treatment failure as defined below, her medical care will be managed at the discretion of the attending physician as per standard of care, and her antibiotic regimen will be unblinded. After delivery, prior to discharge from the hospital, the patient will be asked to answer a short questionnaire enquiring about side effects experienced during treatment for chorioamnionitis. The patient may receive a phone call within 14 days of delivery to assess whether she has received treatment for postpartum complications at an outside institution after discharge from the hospital.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial
Study Start Date : May 2009
Primary Completion Date : September 2014
Estimated Study Completion Date : November 2017


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Unasyn (ampicillin/sulbactam) Drug: Unasyn
Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Active Comparator: Ampicillin/gentamicin Drug: Ampicillin/gentamicin
Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.


Outcome Measures

Primary Outcome Measures :
  1. Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum [ Time Frame: Up to 24 hours after delivery ]
    Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum


Secondary Outcome Measures :
  1. Composite Maternal Morbidity [ Time Frame: Up to 6 weeks after delivery ]
    Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.

  2. Neonatal Clinical Sepsis (Early Onset) [ Time Frame: Up to 6 weeks after delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant women in labor or undergoing induction of labor
  2. Greater than or equal to 18 years of age
  3. 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.

Exclusion Criteria:

  1. Allergy or adverse reaction to penicillin or ampicillin, gentamicin, or sulbactam
  2. Having received antibiotics for the treatment of preterm premature rupture of membranes or other condition within the last 7 days
  3. Acute or chronic renal disease or insufficiency (creatinine >1.0)
  4. Hearing loss
  5. Major fetal congenital anomalies or intrauterine fetal demise
  6. Neutropenia
  7. HIV
  8. Myasthenia gravis or other neuromuscular disorder
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879190


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Natali Aziz, MD Stanford University
More Information

Additional Information:
Publications:
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

Responsible Party: Natali Aziz, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00879190     History of Changes
Other Study ID Numbers: SU-03192009-2018
15562 ( Other Identifier: Stanford University Research Compliance Office )
First Posted: April 9, 2009    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Chorioamnionitis
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Gentamicins
Ampicillin
Sulbactam
Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors