Treatment of Chorioamnionitis After Delivery

• Status: Unknown status
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Naval Medical Center, Portsmouth
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gentamicins

Criteria

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