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Completed

NCT Number: NCT03522909

The Center for Peripartum Optimization

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.

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Key information

Age range

Up to 60 year

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seen in clinic

Other

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

Primary outcomes

  1. Hospital length of stay

    Time frame: 1 year

    Total days of hospital admission

Secondary outcomes

  1. 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

  2. ICU admissions

    Time frame: 1 year

    Whether patient needed ICU admission or transfer

  3. Opioids use

    Time frame: 1 year

    To determine if patient require opioid use

  4. Neonatal Intensive Care Unit (NICU) admissions

    Time frame: 1 year

    Number of times a neonate got admitted to the NICU

  5. Patient satisfaction

    Time frame: 1 year

    Whether patient was satisfied (yes/no) with treatment course based on survey filled out by patient.

  6. Cost of inpatient admission

    Time frame: 1 year

    the entire admission cost of admission during hospital stay

  7. Cost of outpatient care

    Time frame: 1 year

    The cost for outpatient care incurred by patient

  8. Hospital readmissions rate

    Time frame: 1 year

    The number of times a patient got readmitted after discharge

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

The Center for Peripartum Optimization: An Innovative Approach to Care Coordination

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 11, 2018
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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