Antibiotics During Intrauterine Balloon Tamponade Placement

NCT ID: NCT03478163

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-08
• Study Completion Date: 2021-05-03

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.

Conditions

Obstetric Complication; Postpartum Hemorrhage; Postpartum Endometritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

CeFAZolin 1000 MG

Intervention Type: DRUG

Cefazolin 1000 mg every 8 hours for 3 doses

Clindamycin 900 MG in 6 ML Injection

Intervention Type: DRUG

Clindamycin 900 mg every 8 hours for 3 doses

Interventions

CeFAZolin 1000 MG

Cefazolin 1000 mg every 8 hours for 3 doses

Intervention Type: DRUG

Clindamycin 900 MG in 6 ML Injection

Clindamycin 900 mg every 8 hours for 3 doses

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Gregory

Director, Women's Reproductive Health Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly Gregory, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00051005

Identifier Type: -

Identifier Source: org_study_id