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Antibiotics During Intrauterine Balloon Tamponade Placement

Antibiotics During Intrauterine Balloon Tamponade Placement

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03478163
Enrollment
11
Registered
2018-03-27
Start date
2018-03-08
Completion date
2021-05-03
Last updated
2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Complication, Postpartum Hemorrhage, Postpartum Endometritis

Keywords

Bakri, Intrauterine balloon tamponade, Antibiotics

Brief summary

The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.

Detailed description

The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade. Patients who are candidates for study enrollment will be identified on Labor & Delivery or in the Maternal-Fetal Care Unit. Patients who give consent will be randomized by random number generator to receive either antibiotics (Group A) or no antibiotics (Group B). If the patient is randomized to Group A, she 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. If the patient is randomized to Group B, she 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.

Interventions

DRUGCeFAZolin 1000 MG

Cefazolin 1000 mg every 8 hours for 3 doses

DRUGClindamycin 900 MG in 6 ML Injection

Clindamycin 900 mg every 8 hours for 3 doses

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Open label, randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female * Able to give consent * Gestational age \> 24 weeks * Postpartum * Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours * Primary obstetrician amenable to proceeding with either method of management during the study period.

Exclusion criteria

* Age \< 18 years old * IBT removed within 2 hours of placement * Chorioamnionitis * Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes

Design outcomes

Primary

MeasureTime frameDescription
Postpartum Endometritis6 weeksNumber of participants with postpartum endometritis as defined by clinical documentation

Secondary

MeasureTime frameDescription
Receiving Postpartum Antibiotics6 weeksReceiving postpartum antibiotics
Hysterectomy6 weeksHysterectomy
EBL2 weeksEstimated blood loss prior to removal and with IBT in
Postpartum Hemoglobin2 weeksPostpartum hemoglobin value
Number of Participants With a Fever6 weeksNumber of participants with a fever \> 38 degrees celsius
Maternal ICU Admission6 weeksMaternal ICU Admission
Maternal Death6 weeksMaternal death
Resource Utilization Measures6 weeksDuration of admission to maternal-fetal care unit and total hospital admission length of stay
Hospital Readmission6 weeksHospital readmission
Blood Transfusion2 weeksBlood transfusions

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
5
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
6
Total11

Baseline characteristics

CharacteristicControlAntibioticsTotal
Age, Continuous36 years33.83 years34.82 years
Asthma0 Participants3 Participants3 Participants
Balloon Deflation: Rapid or Strep
Rapid
3 Participants6 Participants9 Participants
Balloon Deflation: Rapid or Strep
Strep
2 Participants0 Participants2 Participants
Birthweight3653.33 grams3632.2 grams3640.13 grams
BMI35.28 kg/m^231.5 kg/m^233.01 kg/m^2
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants5 Participants9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
GBS Status
Negative GBS Status
4 Participants6 Participants10 Participants
GBS Status
Positive GBS Status
0 Participants0 Participants0 Participants
Gestational Age at Delivery38.25 weeks39.17 weeks38.8 weeks
Gestational Hypertension or Preeclampsia0 Participants0 Participants0 Participants
Gravidity3 pregnancies1.67 pregnancies2.27 pregnancies
IBT Volume218 cc273.33 cc248.18 cc
Induction1 Participants2 Participants3 Participants
Insurance
HMO / Managed Care
2 Participants1 Participants3 Participants
Insurance
Military
0 Participants1 Participants1 Participants
Insurance
Private
3 Participants4 Participants7 Participants
Labor Augmented by Pitocin2 Participants5 Participants7 Participants
Mode of Delivery
Cesarean Section
4 Participants3 Participants7 Participants
Mode of Delivery
Vaginal
1 Participants3 Participants4 Participants
Multiple Gestation0 Participants1 Participants1 Participants
Number of Serial Deflations
1 Serial Deflations
3 Participants6 Participants9 Participants
Number of Serial Deflations
2 Serial Deflations
2 Participants0 Participants2 Participants
Parity1 pregnancies0.33 pregnancies0.64 pregnancies
Preexisting Hypertension0 Participants1 Participants1 Participants
Previous C-section4 Participants1 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
4 Participants3 Participants7 Participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 6
other
Total, other adverse events
0 / 50 / 6
serious
Total, serious adverse events
0 / 50 / 6

Outcome results

Primary

Postpartum Endometritis

Number of participants with postpartum endometritis as defined by clinical documentation

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlPostpartum Endometritis0 Participants
AntibioticsPostpartum Endometritis3 Participants
Secondary

Blood Transfusion

Blood transfusions

Time frame: 2 weeks

Population: Blood transfusion information unavailable for 1/6 antibiotics participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
ControlBlood Transfusion0 RBC Transfusions3 Participants
ControlBlood Transfusion1 RBC Transfusions0 Participants
ControlBlood Transfusion2 RBC Transfusions2 Participants
ControlBlood Transfusion3 RBC Transfusions0 Participants
AntibioticsBlood Transfusion3 RBC Transfusions1 Participants
AntibioticsBlood Transfusion0 RBC Transfusions0 Participants
AntibioticsBlood Transfusion2 RBC Transfusions2 Participants
AntibioticsBlood Transfusion1 RBC Transfusions2 Participants
Secondary

EBL

Estimated blood loss prior to removal and with IBT in

Time frame: 2 weeks

ArmMeasureGroupValue (MEAN)
ControlEBLEstimated Blood Loss Pre-IBT1626 cc
ControlEBLEstimated Blood Loss with IBT in165.6 cc
AntibioticsEBLEstimated Blood Loss Pre-IBT1385.83 cc
AntibioticsEBLEstimated Blood Loss with IBT in197 cc
Secondary

Hospital Readmission

Hospital readmission

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlHospital Readmission0 Participants
AntibioticsHospital Readmission0 Participants
Secondary

Hysterectomy

Hysterectomy

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlHysterectomy0 Participants
AntibioticsHysterectomy0 Participants
Secondary

Maternal Death

Maternal death

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlMaternal Death0 Participants
AntibioticsMaternal Death0 Participants
Secondary

Maternal ICU Admission

Maternal ICU Admission

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlMaternal ICU Admission0 Participants
AntibioticsMaternal ICU Admission0 Participants
Secondary

Number of Participants With a Fever

Number of participants with a fever \> 38 degrees celsius

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With a Fever0 Participants
AntibioticsNumber of Participants With a Fever3 Participants
Secondary

Postpartum Hemoglobin

Postpartum hemoglobin value

Time frame: 2 weeks

ArmMeasureValue (MEAN)
ControlPostpartum Hemoglobin9.52 g/dL
AntibioticsPostpartum Hemoglobin9.23 g/dL
Secondary

Receiving Postpartum Antibiotics

Receiving postpartum antibiotics

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlReceiving Postpartum Antibiotics0 Participants
AntibioticsReceiving Postpartum Antibiotics3 Participants
Secondary

Resource Utilization Measures

Duration of admission to maternal-fetal care unit and total hospital admission length of stay

Time frame: 6 weeks

Population: Duration of admission to maternal-fetal care unit and total hospital admission information unavailable for 1/5 control participants

ArmMeasureGroupValue (MEAN)
ControlResource Utilization MeasuresMFCU Length of Stay29.75 hours
ControlResource Utilization MeasuresTotal Hospital Length of Stay83.75 hours
AntibioticsResource Utilization MeasuresMFCU Length of Stay30.67 hours
AntibioticsResource Utilization MeasuresTotal Hospital Length of Stay88.83 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026