Antibiotics During Intrauterine Balloon Tamponade Placement

Cedars-Sinai Medical Center

Status and phase: Terminated; Phase 4

Conditions: Postpartum Endometritis; Obstetric Complication; Postpartum Hemorrhage

Treatments: Drug: CeFAZolin 1000 MG; Drug: Clindamycin 900 MG in 6 ML Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03478163

Pro00051005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Antibiotics

Experimental group

Description:

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.

Treatment:

Drug: CeFAZolin 1000 MG

Drug: Clindamycin 900 MG in 6 ML Injection