Antibiotics During Intrauterine Balloon Tamponade Placement

• ClinicalTrials.gov Identifier: NCT03478163
• Recruitment Status: Terminated
• First Posted: March 27, 2018
• Results First Posted: October 7, 2021
• Last Update Posted: October 7, 2021
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Kimberly Gregory, Cedars-Sinai Medical Center

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 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
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: May 3, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Postpartum Endometritis [ Time Frame: 6 weeks ]
   Number of participants with postpartum endometritis as defined by clinical documentation

Secondary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• 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 and Statistical Analysis Plan  [PDF] March 15, 2018

More Information

• Responsible Party: Kimberly Gregory, Director, Women's Reproductive Health Services, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03478163
• Other Study ID Numbers: Pro00051005
• First Posted: March 27, 2018
• Results First Posted: October 7, 2021
• Last Update Posted: October 7, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Postpartum Hemorrhage; Endometritis; Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Pelvic Inflammatory Disease; Adnexal Diseases; Uterine Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action