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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
Sponsor:
Information provided by (Responsible Party):
Natali Aziz, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chorioamnionitis
Interventions Drug: Unasyn
Drug: Ampicillin/gentamicin
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Hide Arm/Group Description Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery. Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Period Title: Overall Study
Started 43 49
Completed 43 49
Not Completed 0 0
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin Total
Hide Arm/Group Description Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery. Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery. Total of all reporting groups
Overall Number of Baseline Participants 43 49 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 49 participants 92 participants
27.6  (7.1) 28.3  (5.6) 28.0  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
Female
43
 100.0%
49
 100.0%
92
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Nulliparous  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
30 39 69
Maternal pre-existing comorbidity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 49 participants 92 participants
19 20 39
1.Primary Outcome
Title Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum
Hide Description Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum
Time Frame Up to 24 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Hide Arm/Group Description:
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Overall Number of Participants Analyzed 43 49
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
49
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unasyn (Ampicillin/Sulbactam), Ampicillin/Gentamicin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Composite Maternal Morbidity
Hide Description Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Hide Arm/Group Description:
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Overall Number of Participants Analyzed 43 49
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6
  12.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ampicillin/Gentamicin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Neonatal Clinical Sepsis (Early Onset)
Hide Description [Not Specified]
Time Frame Up to 6 weeks after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Hide Arm/Group Description:
Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Overall Number of Participants Analyzed 43 49
Measure Type: Number
Unit of Measure: affected neonates
1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unasyn (Ampicillin/Sulbactam), Ampicillin/Gentamicin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events were collected up to 6 weeks after delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Hide Arm/Group Description Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery. Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
All-Cause Mortality
Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/43 (0.00%)      0/49 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Unasyn (Ampicillin/Sulbactam) Ampicillin/Gentamicin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/43 (4.65%)      1/49 (2.04%)    
Infections and infestations     
Postpartum endometritis *  0/43 (0.00%)  0 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders     
Rash *  2/43 (4.65%)  2 0/49 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anna Girsen, Manager of Maternal-Fetal Medicine Research Operations
Organization: Stanford University, Department of Obstetrics & Gynecology
Phone: (650) 725-0499
Publications of Results:
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, 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 Submitted: April 7, 2009
First Posted: April 9, 2009
Results First Submitted: October 31, 2016
Results First Posted: March 15, 2017
Last Update Posted: May 18, 2018