This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Natali Aziz, Stanford University
ClinicalTrials.gov Identifier:
NCT00879190
First received: April 7, 2009
Last updated: April 19, 2017
Last verified: April 2017
Results First Received: October 31, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Unasyn (Ampicillin/Sulbactam) Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Ampicillin/Gentamicin Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.

Participant Flow:   Overall Study
    Unasyn (Ampicillin/Sulbactam)   Ampicillin/Gentamicin
STARTED   43   49 
COMPLETED   43   49 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Unasyn (Ampicillin/Sulbactam) Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
Ampicillin/Gentamicin Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
Total Total of all reporting groups

Baseline Measures
   Unasyn (Ampicillin/Sulbactam)   Ampicillin/Gentamicin   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   49   92 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.6  (7.1)   28.3  (5.6)   28.0  (6.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      43 100.0%      49 100.0%      92 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Nulliparous 
[Units: Participants]
 30   39   69 
Maternal pre-existing comorbidity 
[Units: Participants]
 19   20   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum   [ Time Frame: Up to 24 hours after delivery ]

2.  Secondary:   Composite Maternal Morbidity   [ Time Frame: Up to 6 weeks after delivery ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: agirsen@stanford.edu


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 )
Study First Received: April 7, 2009
Results First Received: October 31, 2016
Last Updated: April 19, 2017