To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
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.
Barnes-Jewish Hospital
St Louis, Missouri, United States
St. Louis University
St Louis, Missouri, United States
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).
Time frame: 7 days post-partum
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.
Time frame: 7 days post-partum
Duration of Hospital Stay After Cesarean Delivery
This is the duration of hospital stay (in days) after their cesarean delivery.
Time frame: Up to 7 Days
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