Clinical Trial: Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

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

Detailed Summary:

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
Sponsor: Washington University School of Medicine

Current Primary Outcome: Endometritis [ Time Frame: 7 days post-partum ]

Endometritis is defined as 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infection-related complications [ Time Frame: 7 days post-partum ]
    To include wound infections, pelvic abscesses, etc.
  • Duration of hospital stay [ Time Frame: 7 days post-partum ]


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: April 23, 2012
Date Started: September 2010
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014