Clinical Trial: Treatment of Chorioamnionitis After Delivery

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Chorioamnionitis After Delivery

Brief 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.

Detailed Summary: Chorioamnionitis refers to infection of the amniotic fluid, membranes, placenta and/or uterus. Clinical chorioamnionitis is defined by a temperature of 380 C or more and one or more of the following findings: maternal heart rate > 100 BPM, baseline fetal heart rate > 160 BPM, uterine tenderness, or foul smelling amniotic fluid. It complicates 0.5 to 10.5 percent of deliveries and accounts for 10 to 40 percent of cases of maternal febrile morbidity in the peripartum period and 50 percent of preterm deliveries before 30 weeks of gestation. Chorioamnionitis is also associated with 20 to 40 percent of cases of early neonatal sepsis and pneumonia. (Hagberg et al). The most extensively tested antibiotic regimen is ampicillin 2 g IV every 6 hours and gentamicin 1.5mg/kg every 8 hours. After delivery clindamycin 900 mg IV q 8 hours can be used for further coverage in those women delivering by cesarean section. The treatment is usually continued until the patient is asymptomatic for 24 - 48 hours although that treatment is primarily based on expert opinion. (Edwards et al). Potential benefits of not needing to treat with antibiotics after a delivery complicated by intramniotic infection is shortened hospital stay and reduced cost. No studies up until now have compared treatment verses no treatment head to head for vaginal delivery and one postpartum dose vs. continued treatment for 24 hours in the women undergoing a cesarean delivery. Unfortunately the Duff study combined patients analyzing both vaginal deliveries and cesarean deliveries together. They were both treated with either the single dose of antibiotics or continual treatment with antibiotics until afebrile and asymptomatic for 24 hours. He found no statistical significant difference in treatment failure in the one dose vs. multiple dose groups. This finding was the primary outcome of the study.Our study will be a double blind placebo controlled randomized study. There will be two arms: vaginal delivery and ce
Sponsor: United States Naval Medical Center, Portsmouth

Current Primary Outcome: To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionitis. [ Time Frame: Postpartum 24 hours ]

Original Primary Outcome: To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionits. [ Time Frame: Postpartum 24 hours ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: United States Naval Medical Center, Portsmouth

Dates:
Date Received: December 23, 2008
Date Started: June 2009
Date Completion: April 2011
Last Updated: August 27, 2009
Last Verified: August 2009