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Antibiotics During Intrauterine Balloon Tamponade Placement

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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

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE March 8, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
Postpartum endometritis [ Time Frame: 6 weeks ]
Incidence of postpartum endometritis as defined by clinical documentation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03478163 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2018)
  • Fever [ Time Frame: 6 weeks ]
    Fever > 38 degrees celsius
  • Wound infection [ Time Frame: 6 weeks ]
    Wound infection
  • Wound breakdown [ Time Frame: 6 weeks ]
    Wound breakdown
  • Receiving postpartum antibiotics [ Time Frame: 6 weeks ]
    Receiving postpartum antibiotics
  • Hysterectomy [ Time Frame: 6 weeks ]
    Hysterectomy
  • Need for additional uterotonics [ Time Frame: 2 weeks ]
    If any of misoprostol, carboprost, or methylergonovine were given after Bakri placement
  • EBL [ Time Frame: 2 weeks ]
    Estimated blood loss prior to removal, following removal, and total
  • Postpartum hemoglobin and hemoglobin change [ Time Frame: 2 weeks ]
    Postpartum hemoglobin and hemoglobin change
  • Blood transfusion [ Time Frame: 2 weeks ]
    Blood transfusions
  • Maternal ICU admission [ Time Frame: 6 weeks ]
    Maternal ICU admission
  • Maternal death [ Time Frame: 6 weeks ]
    Maternal death
  • Resource utilization measures [ Time Frame: 6 weeks ]
    Duration of admission to maternal-fetal care unit and total hospital admission
  • Hospital readmission [ Time Frame: 6 weeks ]
    Hospital readmission
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotics During Intrauterine Balloon Tamponade Placement
Official Title  ICMJE Antibiotics During Intrauterine Balloon Tamponade Placement
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open label, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obstetric Complication
  • Postpartum Hemorrhage
  • Postpartum Endometritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: CeFAZolin 1000 MG
    • Drug: Clindamycin 900 MG in 6 ML Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2018)
185
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Patient must be postpartum
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Melissa S Wong, MD 310-423-0895 Melissa.Wong2@cshs.org
Contact: Kimerly Gregory, MD MPH 3104230895 gregory@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03478163
Other Study ID Numbers  ICMJE Pro00051005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kimberly Gregory, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kimberly Gregory, MD MPH Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP