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Antibiotic

cesarean multiple antibiotics 4 for Chorioamnionitis

N/A
Waitlist Available
Led By Everett F Magann, MD
Research Sponsored by United States Naval Medical Center, Portsmouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postpartum 24 hours
Awards & highlights

Study Summary

Chorioamnionitis occurs in 1% to 5% of term pregnancies and may complicate up to 25% of cases of preterm labor. The traditional regimen used to treat intra-amniotic infection is intravenous ampicillin 2g every 6 hours and intravenous gentamicin 1.5 mg/kg every 8 hrs until delivery . In the past the recommendation has been that the antibiotics be continued postpartum until 24-48 hours afebrile. More recent studies have looked at using a one time dose of antibiotics after delivery vs treating until 24-48 hours afebrile. There have been no studies comparing treatment of chorioamnionitis with antibiotics vs no treatment with antibiotics postpartum. The aim of this study is to compare no treatment vs treatment with one dose after a vaginal delivery and one dose of antibiotics vs a full course until 24 hours afebrile after a cesarean delivery complicated by chorioamnionitis. The hypothesis is that there will be no difference in outcome between the two groups in each arm. This is a randomized study. Once the patient delivers she will be randomized to one of two groups in each arm. First arm (vaginal delivery) A: no treatment, B: treatment with a one time dose of ampicillin/gentamicin; Second arm (c/s) A: one dose of ampicillin/gentamicin/clindamycin, B: treatment with ampicillin/gentamicin and clindamycin until 24 hours afebrile. The goal of the study is to determine the optimal postpartum management of chorioamnionitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postpartum 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and postpartum 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionitis.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: cesarean multiple antibiotics 4Experimental Treatment1 Intervention
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
Group II: cesarean delivery one dose3Experimental Treatment1 Intervention
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)
Group III: vaginal delivery antibotics2Active Control1 Intervention
one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following vaginal delivery
Group IV: vaginal delivery 1Placebo Group1 Intervention
no further antibiotics after delivery (the patient will receive a saline infusion instead of antibiotics)

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, PortsmouthLead Sponsor
31 Previous Clinical Trials
4,032 Total Patients Enrolled
Everett F Magann, MDPrincipal InvestigatorNaval Officer, Naval Medical Center - Portsmouth

Frequently Asked Questions

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~19 spots leftby Apr 2025