NCT03478163

Antibiotics During Intrauterine Balloon Tamponade Placement

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	CeFAZolin 1000 MG	Cefazolin 1000 mg every 8 hours for 3 doses
DRUG	Clindamycin 900 MG in 6 ML Injection	Clindamycin 900 mg every 8 hours for 3 doses

Timeline

• Start date: 2018-03-08
• Primary completion: 2021-05-03
• Completion: 2021-05-03
• First posted: 2018-03-27
• Last updated: 2021-10-07
• Results posted: 2021-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study