Antibiotics During Intrauterine Balloon Tamponade Placement

Phase 4

Terminated

Conditions: Obstetric Complication
Postpartum Hemorrhage
Postpartum Endometritis

Interventions: Drug: CeFAZolin 1000 MG
Drug: Clindamycin 900 MG in 6 ML Injection

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Antibiotics	CeFAZolin 1000 MG	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.
Antibiotics	Clindamycin 900 MG in 6 ML Injection	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.

Primary Outcome Measures

Name	Time	Method
Postpartum Endometritis	6 weeks	Number of participants with postpartum endometritis as defined by clinical documentation

Secondary Outcome Measures

Name	Time	Method
EBL	2 weeks	Estimated blood loss prior to removal and with IBT in
Postpartum Hemoglobin	2 weeks	Postpartum hemoglobin value
Blood Transfusion	2 weeks	Blood transfusions
Number of Participants With a Fever	6 weeks	Number of participants with a fever \> 38 degrees celsius
Receiving Postpartum Antibiotics	6 weeks	Receiving postpartum antibiotics
Hysterectomy	6 weeks	Hysterectomy
Maternal ICU Admission	6 weeks	Maternal ICU Admission
Maternal Death	6 weeks	Maternal death
Resource Utilization Measures	6 weeks	Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Hospital Readmission	6 weeks	Hospital readmission