Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis
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|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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Active Comparator: Unasyn (ampicillin/sulbactam)||
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||
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 ]
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|