Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
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ClinicalTrials.gov Identifier: NCT00879190 |
Recruitment Status :
Completed
First Posted : April 9, 2009
Results First Posted : March 15, 2017
Last Update Posted : May 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chorioamnionitis | Drug: Unasyn Drug: Ampicillin/gentamicin | Phase 2 Phase 3 |
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 |
Actual Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Natali Aziz, MD | Stanford University |
Publications of Results:
Responsible Party: | Natali Aziz, Clinical Assistant Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT00879190 |
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 18, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Chorioamnionitis Fetal Diseases Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Gentamicins |
Ampicillin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |