A Study of the Implementation, Safety, and Outcomes of OB Nest Model of Care for Expectant Mothers
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available