Antibiotics During Intrauterine Balloon Tamponade Placement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antibiotics During Intrauterine Balloon Tamponade Placement

Conditions
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Obstetric Complication, Postpartum Hemorrhage, Postpartum Endometritis

Intervention / Treatment
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* Drug: CeFAZolin 1000 MG
* Drug: Clindamycin 900 MG in 6 ML Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* Cefazolin 1000 mg every 8 hours for 3 doses<br>Drug: Clindamycin 900 MG in 6 ML Injection<br>* Clindamycin 900 mg every 8 hours for 3 doses<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bakri, Intrauterine balloon tamponade, Antibiotics