A Study of the Implementation, Safety, and Outcomes of OB Nest Model of Care for Expectant Mothers

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 13-009513
    NCT ID: NCT02082275
    Sponsor Protocol Number: 13-009513

About this study

The purpose of this study is to test the safety, patient-reported results, and the adoption into practice of a new model of prenatal care called OB Nest. OB nest is intended to create an experience for patients that feels more connected and patient-centered, allowing the patient to visit the clinic less frequently while offering increased communication with the OB nurses and providers through new tools provided to the patient.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • 18+ years of age
  • Documented gestational age less than 13 weeks
  • Pregnancy documented as low risk (see high risk exclusion criteria below)
  • Able to read and understand English
  • Able to provide informed consent (i.e. no impairments or barriers)

Exclusion Criteria

  • Clinical judgment determines the pregnancy is at high risk for complications
    • Severe hypertension >160/110
    • Possible ectopic
    • Congenital adrenal hypertension
    • Prior PE/DVT/stroke
    • Anticoagulation during prior pregnancy (e.g. antiphospholipid antibody syndrome)
    • Prosthetic heart valve (non-bio)
    • Pulmonary hypertension
    • Mothers currently taking
      • Immunosuppressants
      • Prednisone > 10mg per day
      • Antipsychotic (e.g. lithium, Haldol, Zyprexa)
      • Chemotherapy
    • Recurrent pregnancy loss (>2 losses)
    • Current maternal malignancy
    • Prior myocardial infarction/cardiomyopathy
    • Bio-prosthetic heart valves
    • Marfan syndrome
    • Active liver disease (e.g. hepatitis)
    • Congenital heart disease
    • Coagulopathies including thrombophilias and bleeding disorders
    • Pre-existing diabetes
    • Genetic disease/CF testing/anomalies in prior child
    • Incompetent cervix (prior cerclage)
    • Triplets or quads diagnosed by REI or ultrasound
    • Isoimmunization (Rh, Kell, etc.)
    • History of transplant or currently on Dialysis
    • Recurrent pregnancy loss (antiphospholipid antibody syndrome or collagen vascular disease)
    • Chronic hypertension
    • Prior 2nd or 3rd trimester loss
    • HIV
    • Inflammatory bowel disease
    • Asthma and currently on steroid to control disease

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Abimbola Famuyide, M.B.B.S.

Closed for enrollment

Contact information:

Misty Baker R.N., CLC

(507)266-7542

Baker.Misty@mayo.edu

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CLS-20117982

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