Trial Outcomes & Findings for Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (NCT NCT01585129)
NCT ID: NCT01585129
Last Updated: 2018-06-19
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
7 days post-partum
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
41
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
Baseline characteristics by cohort
| Measure |
Postpartum Antibiotics
n=41 Participants
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.
|
No Postpartum Antibiotics
n=39 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 6 • n=5 Participants
|
25.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
25 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-partumEndometritis 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).
Outcome measures
| Measure |
Postpartum Antibiotics
n=41 Participants
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.
|
No Postpartum Antibiotics
n=39 Participants
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.
|
|---|---|---|
|
Number of Paricipants With Endometritis
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 7 days post-partumInfection 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.
Outcome measures
| Measure |
Postpartum Antibiotics
n=41 Participants
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.
|
No Postpartum Antibiotics
n=39 Participants
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.
|
|---|---|---|
|
Number of Participants With Infection-related Complications
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 7 DaysThis is the duration of hospital stay (in days) after their cesarean delivery.
Outcome measures
| Measure |
Postpartum Antibiotics
n=41 Participants
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.
|
No Postpartum Antibiotics
n=39 Participants
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.
|
|---|---|---|
|
Duration of Hospital Stay After Cesarean Delivery
|
4 days
Interval 4.0 to 4.0
|
4 days
Interval 3.0 to 4.0
|
Adverse Events
Postpartum Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Postpartum Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place