The Center for Peripartum Optimization

NCT ID: NCT03522909

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Risk Pregnancy Multidisciplinary Communication Communication Obstetric Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Seen in clinic

Intervention Type OTHER

We 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

Control

A matched controlled group patients not seen at the CPO clinic

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Seen in clinic

We 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* Records of patients seen in CPO clinic that did not deliver at our institution

Exclusion Criteria

* Records of CPO participating parturients outside the specified timeframe.
Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jamie D Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00163559

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fetal Pulse Oximetry Trial (FOX)
NCT00098709 TERMINATED PHASE3
Amniotic Fluid Analysis
NCT06131684 NOT_YET_RECRUITING EARLY_PHASE1