Trial Outcomes & Findings for Antibiotics During Intrauterine Balloon Tamponade Placement (NCT NCT03478163)
NCT ID: NCT03478163
Last Updated: 2021-10-07
Results Overview
Number of participants with postpartum endometritis as defined by clinical documentation
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-10-07
Participant Flow
Participant milestones
| Measure |
Control
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BMI Information for 1/5 control participants unavailable
Baseline characteristics by cohort
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=5 Participants
|
33.83 years
n=6 Participants
|
34.82 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
|
Gravidity
|
3 pregnancies
n=5 Participants
|
1.67 pregnancies
n=6 Participants
|
2.27 pregnancies
n=11 Participants
|
|
Parity
|
1 pregnancies
n=5 Participants
|
0.33 pregnancies
n=6 Participants
|
0.64 pregnancies
n=11 Participants
|
|
Preexisting Hypertension
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
|
Gestational Hypertension or Preeclampsia
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
|
Asthma
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Previous C-section
|
4 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Insurance
HMO / Managed Care
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
|
Insurance
Military
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=11 Participants
|
|
Insurance
Private
|
3 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=11 Participants
|
|
BMI
|
35.28 kg/m^2
n=4 Participants • BMI Information for 1/5 control participants unavailable
|
31.5 kg/m^2
n=6 Participants • BMI Information for 1/5 control participants unavailable
|
33.01 kg/m^2
n=10 Participants • BMI Information for 1/5 control participants unavailable
|
|
Multiple Gestation
|
0 Participants
n=4 Participants • Multiple gestation information unavailable for 1/5 control participants
|
1 Participants
n=6 Participants • Multiple gestation information unavailable for 1/5 control participants
|
1 Participants
n=10 Participants • Multiple gestation information unavailable for 1/5 control participants
|
|
Gestational Age at Delivery
|
38.25 weeks
n=4 Participants • Gestational age information unavailable for 1/5 control participants
|
39.17 weeks
n=6 Participants • Gestational age information unavailable for 1/5 control participants
|
38.8 weeks
n=10 Participants • Gestational age information unavailable for 1/5 control participants
|
|
Birthweight
|
3653.33 grams
n=3 Participants • Birthweight information unavailable for 2/5 control participants and 1/6 antibiotics participants
|
3632.2 grams
n=5 Participants • Birthweight information unavailable for 2/5 control participants and 1/6 antibiotics participants
|
3640.13 grams
n=8 Participants • Birthweight information unavailable for 2/5 control participants and 1/6 antibiotics participants
|
|
Induction
|
1 Participants
n=5 Participants • Induction information unavailable for 1/6 antibiotics participants
|
2 Participants
n=5 Participants • Induction information unavailable for 1/6 antibiotics participants
|
3 Participants
n=10 Participants • Induction information unavailable for 1/6 antibiotics participants
|
|
Labor Augmented by Pitocin
|
2 Participants
n=4 Participants • Labor Augmented by Pitocin information unavailable for 1/5 control participants
|
5 Participants
n=6 Participants • Labor Augmented by Pitocin information unavailable for 1/5 control participants
|
7 Participants
n=10 Participants • Labor Augmented by Pitocin information unavailable for 1/5 control participants
|
|
GBS Status
Positive GBS Status
|
0 Participants
n=4 Participants • GBS status unavailable for 1/5 control participants
|
0 Participants
n=6 Participants • GBS status unavailable for 1/5 control participants
|
0 Participants
n=10 Participants • GBS status unavailable for 1/5 control participants
|
|
GBS Status
Negative GBS Status
|
4 Participants
n=4 Participants • GBS status unavailable for 1/5 control participants
|
6 Participants
n=6 Participants • GBS status unavailable for 1/5 control participants
|
10 Participants
n=10 Participants • GBS status unavailable for 1/5 control participants
|
|
Mode of Delivery
Vaginal
|
1 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=11 Participants
|
|
Mode of Delivery
Cesarean Section
|
4 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=11 Participants
|
|
IBT Volume
|
218 cc
n=5 Participants
|
273.33 cc
n=6 Participants
|
248.18 cc
n=11 Participants
|
|
Balloon Deflation: Rapid or Strep
Rapid
|
3 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=11 Participants
|
|
Balloon Deflation: Rapid or Strep
Strep
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
|
Number of Serial Deflations
1 Serial Deflations
|
3 Participants
n=5 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=11 Participants
|
|
Number of Serial Deflations
2 Serial Deflations
|
2 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber of participants with postpartum endometritis as defined by clinical documentation
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Postpartum Endometritis
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of participants with a fever \> 38 degrees celsius
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Number of Participants With a Fever
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeksReceiving postpartum antibiotics
Outcome measures
| Measure |
Control
n=1 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=3 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Receiving Postpartum Antibiotics
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeksHysterectomy
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Hysterectomy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksEstimated blood loss prior to removal and with IBT in
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
EBL
Estimated Blood Loss Pre-IBT
|
1626 cc
Interval 1400.0 to 1800.0
|
1385.83 cc
Interval 965.0 to 1800.0
|
|
EBL
Estimated Blood Loss with IBT in
|
165.6 cc
Interval 115.0 to 295.0
|
197 cc
Interval 80.0 to 430.0
|
SECONDARY outcome
Timeframe: 2 weeksPostpartum hemoglobin value
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Postpartum Hemoglobin
|
9.52 g/dL
Interval 9.0 to 10.3
|
9.23 g/dL
Interval 8.0 to 10.7
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Blood transfusion information unavailable for 1/6 antibiotics participants
Blood transfusions
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=5 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Blood Transfusion
0 RBC Transfusions
|
3 Participants
|
0 Participants
|
|
Blood Transfusion
1 RBC Transfusions
|
0 Participants
|
2 Participants
|
|
Blood Transfusion
2 RBC Transfusions
|
2 Participants
|
2 Participants
|
|
Blood Transfusion
3 RBC Transfusions
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeksMaternal ICU Admission
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Maternal ICU Admission
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksMaternal death
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Maternal Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Duration of admission to maternal-fetal care unit and total hospital admission information unavailable for 1/5 control participants
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Outcome measures
| Measure |
Control
n=4 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Resource Utilization Measures
MFCU Length of Stay
|
29.75 hours
Interval 19.0 to 53.0
|
30.67 hours
Interval 20.0 to 40.0
|
|
Resource Utilization Measures
Total Hospital Length of Stay
|
83.75 hours
Interval 71.0 to 104.0
|
88.83 hours
Interval 64.0 to 122.0
|
SECONDARY outcome
Timeframe: 6 weeksHospital readmission
Outcome measures
| Measure |
Control
n=5 Participants
The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
|
Antibiotics
n=6 Participants
The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses
|
|---|---|---|
|
Hospital Readmission
|
0 Participants
|
0 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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