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Antibiotics During Intrauterine Balloon Tamponade Placement

Primary Purpose

Obstetric Complication, Postpartum Hemorrhage, Postpartum Endometritis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CeFAZolin 1000 MG
Clindamycin 900 MG in 6 ML Injection
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstetric Complication focused on measuring Bakri, Intrauterine balloon tamponade, Antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Antibiotics

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postpartum Endometritis
Number of participants with postpartum endometritis as defined by clinical documentation

Secondary Outcome Measures

Number of Participants With a Fever
Number of participants with a fever > 38 degrees celsius
Receiving Postpartum Antibiotics
Receiving postpartum antibiotics
Hysterectomy
Hysterectomy
EBL
Estimated blood loss prior to removal and with IBT in
Postpartum Hemoglobin
Postpartum hemoglobin value
Blood Transfusion
Blood transfusions
Maternal ICU Admission
Maternal ICU Admission
Maternal Death
Maternal death
Resource Utilization Measures
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Hospital Readmission
Hospital readmission

Full Information

First Posted
March 12, 2018
Last Updated
September 9, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03478163
Brief Title
Antibiotics During Intrauterine Balloon Tamponade Placement
Official Title
Antibiotics During Intrauterine Balloon Tamponade Placement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Problems with recruitment
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Complication, Postpartum Hemorrhage, Postpartum Endometritis
Keywords
Bakri, Intrauterine balloon tamponade, Antibiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open label, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CeFAZolin 1000 MG
Intervention Description
Cefazolin 1000 mg every 8 hours for 3 doses
Intervention Type
Drug
Intervention Name(s)
Clindamycin 900 MG in 6 ML Injection
Intervention Description
Clindamycin 900 mg every 8 hours for 3 doses
Primary Outcome Measure Information:
Title
Postpartum Endometritis
Description
Number of participants with postpartum endometritis as defined by clinical documentation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With a Fever
Description
Number of participants with a fever > 38 degrees celsius
Time Frame
6 weeks
Title
Receiving Postpartum Antibiotics
Description
Receiving postpartum antibiotics
Time Frame
6 weeks
Title
Hysterectomy
Description
Hysterectomy
Time Frame
6 weeks
Title
EBL
Description
Estimated blood loss prior to removal and with IBT in
Time Frame
2 weeks
Title
Postpartum Hemoglobin
Description
Postpartum hemoglobin value
Time Frame
2 weeks
Title
Blood Transfusion
Description
Blood transfusions
Time Frame
2 weeks
Title
Maternal ICU Admission
Description
Maternal ICU Admission
Time Frame
6 weeks
Title
Maternal Death
Description
Maternal death
Time Frame
6 weeks
Title
Resource Utilization Measures
Description
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Time Frame
6 weeks
Title
Hospital Readmission
Description
Hospital readmission
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patient must be postpartum
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Gregory, MD MPH
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Antibiotics During Intrauterine Balloon Tamponade Placement

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