Antibiotics During Intrauterine Balloon Tamponade Placement

Postpartum Hemorrhage Clinical Trial

Official title:

Antibiotics During Intrauterine Balloon Tamponade Placement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03478163
• Other study ID #: Pro00051005
• Status: Terminated
• Phase: Phase 4
• Start date: March 8, 2018
• Est. completion date: May 3, 2021

Study information

• Verified date: September 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometritis
• Hemorrhage
• Obstetric Complication
• Postpartum Endometritis
• Postpartum Hemorrhage

Intervention

Drug:
• CeFAZolin 1000 MG
Cefazolin 1000 mg every 8 hours for 3 doses
• Clindamycin 900 MG in 6 ML Injection
Clindamycin 900 mg every 8 hours for 3 doses

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum Endometritis	Number of participants with postpartum endometritis as defined by clinical documentation	6 weeks
Secondary	Number of Participants With a Fever	Number of participants with a fever > 38 degrees celsius	6 weeks
Secondary	Receiving Postpartum Antibiotics	Receiving postpartum antibiotics	6 weeks
Secondary	Hysterectomy	Hysterectomy	6 weeks
Secondary	EBL	Estimated blood loss prior to removal and with IBT in	2 weeks
Secondary	Postpartum Hemoglobin	Postpartum hemoglobin value	2 weeks
Secondary	Blood Transfusion	Blood transfusions	2 weeks
Secondary	Maternal ICU Admission	Maternal ICU Admission	6 weeks
Secondary	Maternal Death	Maternal death	6 weeks
Secondary	Resource Utilization Measures	Duration of admission to maternal-fetal care unit and total hospital admission length of stay	6 weeks
Secondary	Hospital Readmission	Hospital readmission	6 weeks