Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Phase 4

Terminated

• Conditions: The Primary Outcome of This Study Will be the Rate of Endometritis
• Interventions: Drug: Postpartum Antibiotics; Drug: No postpartum antibiotics

• Registration Number: NCT01585129
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2018-01-25
• Results First Submitted QC: 2018-04-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Results First Posted: 2018-05-22
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Clinical diagnosis of chorioamnionitis
• Undergoing cesarean section for delivery

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postpartum Antibiotics	Postpartum Antibiotics	Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
No postpartum antibiotics	No postpartum antibiotics	No further postpartum antibiotics

Primary Outcome Measures

Name	Time	Method
Number of Paricipants With Endometritis	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 Outcome Measures

Name	Time	Method
Number of Participants With Infection-related Complications	7 days post-partum	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.
Duration of Hospital Stay After Cesarean Delivery	Up to 7 Days	This is the duration of hospital stay (in days) after their cesarean delivery.

Trial Locations

Locations (2)

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States