The Primary Outcome of This Study Will be the Rate of Endometritis
Conditions
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.
Interventions
DRUGPostpartum Antibiotics
Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
DRUGNo postpartum antibiotics
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.
Sponsors
St. Louis University
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Postpartum Antibiotics Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
Postpartum Antibiotics: Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting. | 41 |
| No Postpartum Antibiotics No further postpartum antibiotics
No postpartum antibiotics: 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. | 39 |
| Total | 80 |
Baseline characteristics
| Characteristic | No Postpartum Antibiotics | Total | Postpartum Antibiotics |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 80 Participants | 41 Participants |
| Age, Continuous | 25.3 years STANDARD_DEVIATION 6.6 | 25 years STANDARD_DEVIATION 6 | 24.7 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 49 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 13 Participants |
| Region of Enrollment United States | 39 Participants | 80 Participants | 41 Participants |
| Sex: Female, Male Female | 39 Participants | 80 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Antibiotics | Number of Paricipants With Endometritis | 4 Participants |
| No Postpartum Antibiotics | Number of Paricipants With Endometritis | 3 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Postpartum Antibiotics | Duration of Hospital Stay After Cesarean Delivery | 4 days |
| No Postpartum Antibiotics | Duration of Hospital Stay After Cesarean Delivery | 4 days |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postpartum Antibiotics | Number of Participants With Infection-related Complications | 7 Participants |
| No Postpartum Antibiotics | Number of Participants With Infection-related Complications | 2 Participants |