EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorColumbia University
About this trial
Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Maternal Sepsis Safety Bundle
BehavioralMaternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.
Treatment groups
33,183 Participants
are divided into 1 treatment groupGroup A: Patients Admitted for Delivery (Comparing Pre vs Post-Implementation)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Diagnosed with Maternal Sepsis
The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).
Time frame
Delivery AdmissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Northern Manhattan Perinatal Partnership
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov