Chorioamnionitis | Treatment of Chorioamnionitis After Delivery
Chorioamnionitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:salineA saline infusion after delivery (one dose)
Drug:ampicillin gentamicinone additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following their vaginal delivery
Drug:Ampicillin gentamicin clindamycinone 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)
Drug:ampicillin gentamicin clindamycinampicillin 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
vaginal delivery 1no further antibiotics after delivery (the patient will receive a saline infusion instead of antibiotics)
vaginal delivery antibotics2one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following vaginal delivery
cesarean delivery one dose3one 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 4ampicillin 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
Start Date: June 2009
Completed Date: April 2011
Primary Outcome: To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionitis.
Study sponsors, principal investigator, and references
Principal Investigator: Everett F Magann, MD
Lead Sponsor: United States Naval Medical Center, Portsmouth