Skip to main content
Clinical Trials/NCT01585129
NCT01585129
Terminated
Phase 4

Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Washington University School of Medicine2 sites in 1 country80 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
Postpartum Antibiotics
Conditions
The Primary Outcome of This Study Will be the Rate of Endometritis
Sponsor
Washington University School of Medicine
Enrollment
80
Locations
2
Primary Endpoint
Number of Paricipants With Endometritis
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.

Detailed Description

Bacterial infection of the amniotic cavity, termed "chorioamnionitis", is a major cause of perinatal mortality and maternal morbidity. Early administration of broad-spectrum antibiotic therapy in the laboring patient with chorioamnionitis has both neonatal and maternal benefits. Less known is the ideal postpartum antibiotic regimen - or if postpartum antibiotics are even required at all - needed to decrease febrile morbidity. Current practice has seen a wide range of practice styles ranging from no treatment to antibiotic prophylaxis for up to 48 hours after delivery. If antibiotics are prescribed, there is good evidence to support one additional dose of antibiotics as compared to 24 hour dosing to decrease the rate of endometritis. Less clear is whether antibiotics are required at all for the properly treated patient with chorioamnionitis who requires a cesarean delivery. One study comparing continued antibiotics versus no-treatment failed to show a difference in the rate of postpartum endometritis. The conclusion from this study was that continuation of preoperative clindamycin and gentamicin in the postoperative period did not reduce the risk of endometritis compared to a single preoperative dose however this study was terminated early due to failure to recruit their stated sample size. Puerperal endometritis rates vary by mode of delivery but it is known that the rate is lower in vaginal deliveries as compared to cesarean delivery. The patient with chorioamnionitis that requires a cesarean delivery makes an excellent study target. Given the lack of studied protocols, there currently are many acceptable methods for treating the patient with chorioamnionitis. Our proposed study plans to evaluate the two most common methods of treatment to determine the most effective regimen. If post-delivery antibiotics do not show a benefit to these highest risk subjects, it is likely inferred that patients that undergo a vaginal delivery will not require antibiotics as well. Specific Aims There is conflicting data regarding the necessity of post-delivery antibiotics for patients with chorioamnionitis who undergo cesarean delivery. The primary objective of this study is to determine if postpartum antibiotics are necessary for antepartum treated cases of chorioamnionitis in patients undergoing a cesarean section.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
July 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of chorioamnionitis
  • Undergoing cesarean section for delivery

Exclusion Criteria

  • Multiple gestations,
  • Allergy to beta-lactam antibiotics
  • Patients with estimated creatinine clearance (ClCr) less than 70 mL/min
  • Maternal fever explained by etiology other than chorioamnionitis
  • Inability to comply with the study protocol.

Arms & Interventions

Postpartum Antibiotics

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

Intervention: Postpartum Antibiotics

No postpartum antibiotics

No further postpartum antibiotics

Intervention: No postpartum antibiotics

Outcomes

Primary Outcomes

Number of Paricipants With Endometritis

Time Frame: 7 days post-partum

Endometritis is defined as uterine infection and is diagnosed by maternal temp \> 38.0C on two occasions over a 4 hour period or any temp \> 39.0C after delivery \> 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).

Secondary Outcomes

  • Number of Participants With Infection-related Complications(7 days post-partum)
  • Duration of Hospital Stay After Cesarean Delivery(Up to 7 Days)

Study Sites (2)

Loading locations...

Similar Trials