Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

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

Detailed Description
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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.

Official Title
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Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Conditions
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The Primary Outcome of This Study Will be the Rate of Endometritis

Intervention / Treatment
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* Drug: Postpartum Antibiotics
* Drug: No postpartum antibiotics


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postpartum Antibiotics<br>Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin) | Drug: Postpartum Antibiotics<br>* Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.<br>|
| Placebo Comparator: No postpartum antibiotics<br>No further postpartum antibiotics | Drug: No postpartum antibiotics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Paricipants With Endometritis | 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). | 7 days post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Infection-related Complications | Infection related complications will include common complications attributed to infections there are not the primary outcome (endometritis). This will include infections of the wound and pelvic abscesses. | 7 days post-partum | 
| Duration of Hospital Stay After Cesarean Delivery | This is the duration of hospital stay (in days) after their cesarean delivery. | Up to 7 Days |