High Risk PregnancyNCT03522909
The Center for Peripartum Optimization
An observational study of High Risk Pregnancy and Multidisciplinary Communication, run by Johns Hopkins University at 1 site in United States.
Trial summary
In January 2017 investigators started a Center for Peripartum Optimization (CPO) with the aim of optimizing a patient's clinical status in an outpatient setting to minimize unnecessary laboratory tests and studies, costly inpatient consultations, the likelihood of post-surgical adverse events, escalations in level of… Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- High Risk Pregnancy, Multidisciplinary Communication, Communication
- What is being tested?
- Seen in clinic
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Center for Peripartum Optimization: An Innovative Approach to Care Coordination
In January 2017 investigators started a Center for Peripartum Optimization (CPO) with the aim of optimizing a patient's clinical status in an outpatient setting to minimize unnecessary laboratory tests and studies, costly inpatient consultations, the likelihood of post-surgical adverse events, escalations in level of care, inpatient admissions and readmissions. This research project seeks to evaluate the impact of this innovative concept on patient outcomes during the last 12 months. Investigators will accomplish this by collecting retrospective data from patients' electronic medical records in the intervention group and comparing it to data gathered from a controlled group of patients with similar comorbidities but who were not evaluated at the CPO clinic.
- Conditions
- High Risk Pregnancy, Multidisciplinary Communication, Communication, Obstetric Complication
- Being tested
- Seen in clinic
- Keywords
- obstetric anesthesia, telemedicine
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seen in clinicOther
We will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for:
- Primary outcome variable.
- Hospital length of stay
- Secondary outcome variables.
- Number of admissions from outside hospitals
- Adverse outcomes
- Intensive Care Unit admissions
- Opioid use
- NICU admissions
- Patient satisfaction
- Cost of inpatient admission
- Cost of outpatient care
- Hospital readmissions rate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Seen in clinic | |
| Control | A matched controlled group patients not seen at the CPO clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Total days of hospital admission
Measured: 1 year
Secondary outcomes (8)
Number of admissions from outside hospitals
The total number of admissions to any other hospitals prior to admission or after discharge
Measured: 1 year
ICU admissions
Whether patient needed ICU admission or transfer
Measured: 1 year
Opioids use
To determine if patient require opioid use
Measured: 1 year
Neonatal Intensive Care Unit (NICU) admissions
Number of times a neonate got admitted to the NICU
Measured: 1 year
Patient satisfaction
Whether patient was satisfied (yes/no) with treatment course based on survey filled out by patient.
Measured: 1 year
Cost of inpatient admission
the entire admission cost of admission during hospital stay
Measured: 1 year
Cost of outpatient care
The cost for outpatient care incurred by patient
Measured: 1 year
Hospital readmissions rate
The number of times a patient got readmitted after discharge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study startJan 2017
- Primary completionJan 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie D Murphy, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522909
- Sponsor's protocol ID
- IRB00163559
- Status last verified
- Jul 2020
- First submitted
- 1 May 2018
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Center for Peripartum Optimization: An Innovative Approach to Care Coordination
- ClinicalTrials.gov ID
- NCT03522909
- Acronym / sponsor ID
- IRB00163559
- Conditions
- High Risk Pregnancy, Multidisciplinary Communication, Communication, Obstetric Complication
- Keywords
- obstetric anesthesia, telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In January 2017 investigators started a Center for Peripartum Optimization (CPO) with the aim of optimizing a patient's clinical status in an outpatient setting to minimize unnecessary laboratory tests and studies, costly inpatient consultations, the likelihood of post-surgical adverse events, escalations in level of care, inpatient admissions and readmissions. This research project seeks to evaluate the impact of this innovative concept on patient outcomes during the last 12 months. Investigators will accomplish this by collecting retrospective data from patients' electronic medical records in the intervention group and comparing it to data gathered from a controlled group of patients with similar comorbidities but who were not evaluated at the CPO clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Other: Seen in clinicWe 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 |
| Control | – | –A matched controlled group patients not seen at the CPO clinic |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (14 listed)
- 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.)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seen in clinicWe will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for: 1. Primary outcome variable. - Hospital length of stay 2. Secondary outcome variables. * Number of admissions from outside hospitals * Adverse outcomes * Intensive Care Unit admissions * Opioid use * NICU admissions * Patient satisfaction * Cost of inpatient admission * Cost of outpatient care * Hospital readmissions rate | Other | Study |
Primary outcome
Hospital length of stay
Time frame: 1 year
Total days of hospital admission
8 secondary outcomes
Number of admissions from outside hospitals
Time frame: 1 year
ICU admissions
Time frame: 1 year
Opioids use
Time frame: 1 year
Neonatal Intensive Care Unit (NICU) admissions
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Cost of inpatient admission
Time frame: 1 year
Cost of outpatient care
Time frame: 1 year
Hospital readmissions rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie D Murphy, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Pregnancy and Multidisciplinary Communication, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021; AzTrials last refreshed its copy on 28 Oct 2026.