Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)
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|ClinicalTrials.gov Identifier: NCT01585129|
Recruitment Status : Terminated (The trial was stopped for futility in patient enrollment following a planned interim analysis after 80 patients were randomized.)
First Posted : April 25, 2012
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|The Primary Outcome of This Study Will be the Rate of Endometritis in the Study Population||Drug: Postpartum Antibiotics Drug: No postpartum antibiotics||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment Utility of Postpartum Antibiotics in Chorioamnionitis|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Postpartum Antibiotics
Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
Drug: Postpartum Antibiotics
Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
Placebo Comparator: No postpartum antibiotics
No further postpartum antibiotics
Drug: No postpartum antibiotics
Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops.
- 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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585129
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|St. Louis University|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Anthony L Shanks, MD||Washington University School of Medicine|