Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)

The Washington University

Status and phase: Terminated; Phase 4

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

Treatments: Drug: No postpartum antibiotics; Drug: Postpartum Antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01585129

09-0704

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Postpartum Antibiotics

Experimental group

Description:

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

Treatment:

Drug: Postpartum Antibiotics

No postpartum antibiotics

Placebo Comparator group

Description:

No further postpartum antibiotics

Treatment:

Drug: No postpartum antibiotics