Clinical trial NCT03478163: Antibiotics During Intrauterine Balloon Tamponade Placement
Official title: Antibiotics During Intrauterine Balloon Tamponade Placement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obstetric Complication
Postpartum Hemorrhage
Postpartum Endometritis
Keywords: Bakri
Intrauterine balloon tamponade
Antibiotics
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, randomized controlled trial
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Postpartum Endometritis
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants With a Fever
timeFrame: 6 weeks
measure: Receiving Postpartum Antibiotics
timeFrame: 6 weeks
measure: Hysterectomy
timeFrame: 6 weeks
measure: EBL
timeFrame: 2 weeks
measure: Postpartum Hemoglobin
timeFrame: 2 weeks
measure: Blood Transfusion
timeFrame: 2 weeks
measure: Maternal ICU Admission
timeFrame: 6 weeks
measure: Maternal Death
timeFrame: 6 weeks
measure: Resource Utilization Measures
timeFrame: 6 weeks
measure: Hospital Readmission
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Kimberly Gregory, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: