TerminatedPhase 4

Antibiotics During Intrauterine Balloon Tamponade Placement

Stopped: Problems with recruitment

United States11 participantsStarted 2018-03-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Postpartum Endometritis

Timeframe: 6 weeks

Trial details

NCT IDNCT03478163

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-03

Results submitted2021-06-04

View on ClinicalTrials.gov More Obstetric Complication trials