Treatment Utility of Postpartum Antibiotics in Chorioamnionitis



Status:Terminated
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:14 - 50
Updated:6/21/2018
Start Date:September 2010
End Date:July 2014

Use our guide to learn which trials are right for you!

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.

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.
We found this trial at
2
sites
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials