Antibiotics During Intrauterine Balloon Tamponade Placement

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.

Study Overview

• Status: Terminated
• Conditions: Postpartum Hemorrhage; Obstetric Complication; Postpartum Endometritis
• Intervention / Treatment: Drug: CeFAZolin 1000 MG; Drug: Clindamycin 900 MG in 6 ML Injection

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: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Endometritis	Number of participants with postpartum endometritis as defined by clinical documentation	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Fever	Number of participants with a fever > 38 degrees celsius	6 weeks
Receiving Postpartum Antibiotics	Receiving postpartum antibiotics	6 weeks
Hysterectomy	Hysterectomy	6 weeks
EBL	Estimated blood loss prior to removal and with IBT in	2 weeks
Postpartum Hemoglobin	Postpartum hemoglobin value	2 weeks
Blood Transfusion	Blood transfusions	2 weeks
Maternal ICU Admission	Maternal ICU Admission	6 weeks
Maternal Death	Maternal death	6 weeks
Resource Utilization Measures	Duration of admission to maternal-fetal care unit and total hospital admission length of stay	6 weeks
Hospital Readmission	Hospital readmission	6 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Kimberly Gregory, MD MPH, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Antibiotics; Bakri; Intrauterine balloon tamponade
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Adnexal Diseases; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Pelvic Inflammatory Disease; Hemorrhage; Postpartum Hemorrhage; Endometritis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin
• Other Study ID Numbers: Pro00051005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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