Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibiotics During Intrauterine Balloon Tamponade Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03478163
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Kimberly Gregory, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Drug: CeFAZolin 1000 MG Drug: Clindamycin 900 MG in 6 ML Injection Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibiotics During Intrauterine Balloon Tamponade Placement
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Drug: CeFAZolin 1000 MG
Cefazolin 1000 mg every 8 hours for 3 doses

Drug: Clindamycin 900 MG in 6 ML Injection
Clindamycin 900 mg every 8 hours for 3 doses




Primary Outcome Measures :
  1. Postpartum endometritis [ Time Frame: 6 weeks ]
    Incidence of postpartum endometritis as defined by clinical documentation


Secondary Outcome Measures :
  1. Fever [ Time Frame: 6 weeks ]
    Fever > 38 degrees celsius

  2. Wound infection [ Time Frame: 6 weeks ]
    Wound infection

  3. Wound breakdown [ Time Frame: 6 weeks ]
    Wound breakdown

  4. Receiving postpartum antibiotics [ Time Frame: 6 weeks ]
    Receiving postpartum antibiotics

  5. Hysterectomy [ Time Frame: 6 weeks ]
    Hysterectomy

  6. Need for additional uterotonics [ Time Frame: 2 weeks ]
    If any of misoprostol, carboprost, or methylergonovine were given after Bakri placement

  7. EBL [ Time Frame: 2 weeks ]
    Estimated blood loss prior to removal, following removal, and total

  8. Postpartum hemoglobin and hemoglobin change [ Time Frame: 2 weeks ]
    Postpartum hemoglobin and hemoglobin change

  9. Blood transfusion [ Time Frame: 2 weeks ]
    Blood transfusions

  10. Maternal ICU admission [ Time Frame: 6 weeks ]
    Maternal ICU admission

  11. Maternal death [ Time Frame: 6 weeks ]
    Maternal death

  12. Resource utilization measures [ Time Frame: 6 weeks ]
    Duration of admission to maternal-fetal care unit and total hospital admission

  13. Hospital readmission [ Time Frame: 6 weeks ]
    Hospital readmission



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient must be postpartum
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478163


Contacts
Layout table for location contacts
Contact: Melissa S Wong, MD 310-423-0895 Melissa.Wong2@cshs.org
Contact: Kimerly Gregory, MD MPH 3104230895 gregory@cshs.org

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Melissa S Wong, MD    310-423-0895    Melissa.Wong2@cshs.org   
Contact: Kimberly Gregory, MD MPH    3104230895    gregory@cshs.org   
Principal Investigator: Kimberly D Gregory, MD MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kimberly Gregory, MD MPH Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Kimberly Gregory, Cedars-Sinai Medical Center:
Study Protocol  [PDF] March 15, 2018


Layout table for additonal information
Responsible Party: Kimberly Gregory, Director, Women's Reproductive Health Services, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03478163     History of Changes
Other Study ID Numbers: Pro00051005
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Kimberly Gregory, Cedars-Sinai Medical Center:
Bakri
Intrauterine balloon tamponade
Antibiotics
Additional relevant MeSH terms:
Layout table for MeSH terms
Postpartum Hemorrhage
Endometritis
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action