Antibiotics During Intrauterine Balloon Tamponade Placement

NCT03478163 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00051005
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Complication; Postpartum Hemorrhage; Postpartum Endometritis

Keywords

Bakri; Intrauterine balloon tamponade; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Postpartum Endometritis

  Number of participants with postpartum endometritis as defined by clinical documentation

  6 weeks

Secondary Outcomes (10)

• Number of Participants With a Fever

  6 weeks

• Receiving Postpartum Antibiotics

  6 weeks

• Hysterectomy

  6 weeks

• EBL

  2 weeks

• Postpartum Hemoglobin

  2 weeks

Study Arms (2)

Control

NO INTERVENTION

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

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; Drug: Clindamycin 900 MG in 6 ML Injection

Interventions

CeFAZolin 1000 MG DRUG

Cefazolin 1000 mg every 8 hours for 3 doses

Antibiotics

Clindamycin 900 MG in 6 ML Injection DRUG

Clindamycin 900 mg every 8 hours for 3 doses

Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient must be postpartum
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Cefazolin; Clindamycin; Injections

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Melissa Wong, MD MHDS
• Organization: Cedars Sinai

wongmsx@cshs.org

310-423-0895

Study Officials

• Kimberly Gregory, MD MPH

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Women's Reproductive Health Services

Model Details: Open label, randomized controlled trial

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 27, 2018
• Study Start: March 8, 2018
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)