Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
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ClinicalTrials.gov Identifier: NCT00185991 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : June 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chorioamnionitis | Drug: gentamicin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Once daily Gentamicin |
Drug: gentamicin
Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours). |
Active Comparator: Every eight hour Gentamicin |
Drug: gentamicin
Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours). |
- Afebrile at 24 hours and no endometritis [ Time Frame: 24 hours after delivery ]
- Neonatal outcomes [ Time Frame: Time of delivery to time of discharge ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- clinical diagnosis of chorioamnionitis
Exclusion Criteria:
- maternal renal disease, intrauterine fetal death, allergy to gentamicin

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): NCT00185991
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Yasser Yehia El-Sayed | Stanford University |
Responsible Party: | Yasser Yehia El-Sayed, Stanford University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00185991 |
Other Study ID Numbers: |
80104 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | June 15, 2011 |
Last Verified: | June 2011 |
Chorioamnionitis Fetal Diseases Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases |
Gentamicins Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |