- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522909
The Center for Peripartum Optimization
The Center for Peripartum Optimization: An Innovative Approach to Care Coordination
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This will be a retrospective study design utilizing the Johns Hopkins Hospital (JHH) electronic medical record system (EMR) "EPIC". We will be reviewing records of parturients seen at JHH in the Center for Peripartum Optimization (CPO) clinic between January 2017 to January 2018 and comparing outcome data with a matched controlled group patients not seen at the CPO clinic. This matched controlled parturient group will be identified utilizing the JHH EMR and ICD-10 comorbidity codes.
These patients will be female of child-bearing age that fits into the inclusion criteria.
Description
Inclusion Criteria:
- Records of all female, obstetric patients of child-bearing age who were evaluated in the Center for Peripartum Optimization during the period between January 2017 and January 2018.
- Controlled group will include parturients with match high risk comorbidities or history of nonobstetric surgery during pregnancy who delivered at Johns Hopkins Hospital (JHH) during July 1, 2016 - Dec 31, 2016
- Patients with any one or more of these high risk comorbidities:
- Complex spine pathologies (Scoliosis, vertebral fusion, disc disease, spinal canal defects, neuropathies, and nerve disease, etc.)
- Neurological pathology (Cerebral ischemia, tumor, increased intracranial pressure, cerebral vascular disease, etc.)
- Cardiac disease (Congenital, valvular, pulmonary hypertension, cardiomyopathy, ischemic disease, arrhythmia, etc.)
- Pulmonary disease (History of pulmonary embolism, interstitial lung disease, severe asthma, cancer, etc.)
- Morbid Obesity (Obstructive Sleep Apnea, equipment considerations)
- Hematologic Disorders (Thrombophilias, coagulopathies, patients on anticoagulation)
- Cancer
- Abnormal placentation (Previa, accreta / increta / percreta)
- Anesthetic concerns (Airway abnormalities, history of adverse anesthetic reactions or experiences (i.e. recall, anaphylaxis))
- Fetal therapy patients requiring specialized management (Ex utero intrapartum treatment (EXIT), Fetoscopic endotracheal occlusion (FETO), Twin-to-twin transfusion syndrome (TTTS), Percutaneous Umbilical Blood Sampling (PUBS), etc.)
- Chronic Pain
Exclusion Criteria:
- Records of CPO participating parturients outside the specified timeframe.
- Records of obstetric patients of child-bearing age without high-risk comorbid conditions described in inclusion criteria.
- Records of patients seen in CPO clinic that did not deliver at our institution
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study
We will be reviewing records of parturients seen at Johns Hopkins Hospital in the Center for Peripartum Optimization (CPO) clinic between January 2017 to January 2018
|
We will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for:
|
Control
A matched controlled group patients not seen at the CPO clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital length of stay
Time Frame: 1 year
|
Total days of hospital admission
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of admissions from outside hospitals
Time Frame: 1 year
|
The total number of admissions to any other hospitals prior to admission or after discharge
|
1 year
|
ICU admissions
Time Frame: 1 year
|
Whether patient needed ICU admission or transfer
|
1 year
|
Opioids use
Time Frame: 1 year
|
To determine if patient require opioid use
|
1 year
|
Neonatal Intensive Care Unit (NICU) admissions
Time Frame: 1 year
|
Number of times a neonate got admitted to the NICU
|
1 year
|
Patient satisfaction
Time Frame: 1 year
|
Whether patient was satisfied (yes/no) with treatment course based on survey filled out by patient.
|
1 year
|
Cost of inpatient admission
Time Frame: 1 year
|
the entire admission cost of admission during hospital stay
|
1 year
|
Cost of outpatient care
Time Frame: 1 year
|
The cost for outpatient care incurred by patient
|
1 year
|
Hospital readmissions rate
Time Frame: 1 year
|
The number of times a patient got readmitted after discharge
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jamie D Murphy, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00163559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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