Treatment of Chorioamnionitis After Delivery

NCT00814905 | Withdrawn

• 1 other identifier: PO8-098
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chorioamnionitis

Keywords

chorioamnionitis; antibiotics; cesarean; vaginal delivery

Outcome Measures

Primary Outcomes (1)

• To determine the courses of antibiotics needed after vaginal delivery and after cesareans in pregnancies complicated by chorioamnionitis.

  Postpartum 24 hours

Study Arms (4)

vaginal delivery 1

PLACEBO COMPARATOR

no further antibiotics after delivery (the patient will receive a saline infusion instead of antibiotics)

Drug: saline

vaginal delivery antibotics2

ACTIVE COMPARATOR

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

Drug: ampicillin gentamicin

cesarean delivery one dose3

OTHER

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

cesarean multiple antibiotics 4

OTHER

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

Drug: ampicillin gentamicin clindamycin

Interventions

saline DRUG

A saline infusion after delivery (one dose)

vaginal delivery 1

ampicillin gentamicin DRUG

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

vaginal delivery antibotics2

ampicillin gentamicin clindamycin DRUG

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)

cesarean delivery one dose3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients that develop chorioamnionitis and who are over 18 years of age will be offered participation in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

MeSH Terms

Conditions

Chorioamnionitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Everett F Magann, MD

  Naval Officer, Naval Medical Center - Portsmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 25, 2008
• Study Start: November 18, 2008
• Primary Completion: January 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)