Antibiotics During Intrauterine Balloon Tamponade Placement



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:March 8, 2018
End Date:December 31, 2021
Contact:Melissa S Wong, MD
Email:Melissa.Wong2@cshs.org
Phone:310-423-0895

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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.

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.

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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Kimberly D Gregory, MD MPH
Phone: 310-423-0895
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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