Treatment of Chorioamnionitis After Delivery
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ClinicalTrials.gov Identifier: NCT00814905 |
Recruitment Status
: Unknown
Verified August 2009 by United States Naval Medical Center, Portsmouth.
Recruitment status was: Recruiting
First Posted
: December 25, 2008
Last Update Posted
: August 28, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chorioamnionitis | Drug: saline Drug: ampicillin gentamicin Drug: Ampicillin gentamicin clindamycin Drug: ampicillin gentamicin clindamycin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Chorioamnionitis After Delivery |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | January 2011 |
Estimated Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: vaginal delivery 1
no further antibiotics after delivery (the patient will receive a saline infusion instead of antibiotics)
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Drug: saline
A saline infusion after delivery (one dose)
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Active Comparator: vaginal delivery antibotics2
one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following vaginal delivery
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Drug: ampicillin gentamicin
one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following their vaginal delivery
|
cesarean delivery one dose3
one dose of ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV, clindamycin 900 mg IV and then saline infusions instead of antibiotics until they are afebrile for 24 hours ( they will receive saline infusions instead of antibiotics)
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Drug: Ampicillin gentamicin clindamycin
one dose of ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV, clindamycin 900 mg IV and then saline infusions instead of antibiotics until they are afebrile for 24 hours ( they will receive saline infusions instead of antibiotics)
|
cesarean multiple antibiotics 4
ampicillin 2 g IV every 6 hours, gentamicin 1.5mg/kg every 8 hours, and clindamycin 900 mg IV every 8 hours until the patient has been afebrile for 24 hours
|
Drug: ampicillin gentamicin clindamycin
ampicillin 2 g IV every 6 hours, gentamicin 1.5mg/kg every 8 hours, and clindamycin 900 mg IV every 8 hours until the patient has been afebrile for 24 hours
|
- To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionitis. [ Time Frame: Postpartum 24 hours ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:.
- All patients that develop chorioamnionitis and who are over 18 years of age will be offered participation in the study.
Exclusion Criteria:
- Women who do not wish to participate, patients who are allergic to the study antibiotics
- Women who are immunocompromised or women receiving antibiotics for other reasons such as prophylaxis for bacterial endocarditis

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): NCT00814905
Contact: Everett F Magann, MD | 757-953-4293 | everett.magann@med.navy.mil |
United States, Virginia | |
Naval Medical Center - Portsmouth | Recruiting |
Portsmouth, Virginia, United States, 23708-2197 | |
Sub-Investigator: Rebecca Staben, DO |
Principal Investigator: | Everett F Magann, MD | Naval Officer, Naval Medical Center - Portsmouth |
Responsible Party: | Thomas S. Rieg PhD / Department Head, Naval Medical Center - Portsmouth |
ClinicalTrials.gov Identifier: | NCT00814905 History of Changes |
Other Study ID Numbers: |
PO8-098 |
First Posted: | December 25, 2008 Key Record Dates |
Last Update Posted: | August 28, 2009 |
Last Verified: | August 2009 |
Keywords provided by United States Naval Medical Center, Portsmouth:
chorioamnionitis antibiotics cesarean vaginal delivery |
Additional relevant MeSH terms:
Chorioamnionitis Fetal Diseases Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Anti-Bacterial Agents Clindamycin Clindamycin palmitate |
Clindamycin phosphate Gentamicins Ampicillin Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |