Treatment of Chorioamnionitis After Delivery

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.

Conditions

• Chorioamnionitis

Interventions

DRUG

saline

A saline infusion after delivery (one dose)

DRUG

ampicillin gentamicin

one additional dose of antibiotics (ampicillin 2 grams IV, gentamicin 1.5 mg/kg IV) following their vaginal delivery

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)

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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth

  lead FED

Principal Investigators

• Everett F Magann, MD · Naval Officer, Naval Medical Center - Portsmouth

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-11-18

Primary Completion

2012-01-31

Completion

2012-09-30

Countries

• United States

Study Locations