OB Nest; Redefining Continuity of Care for Expectant Mothers
Study type: Interventional What is this?
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.
- Rochester, Minnesota: 13-009513
NCT ID: NCT02082275
Sponsor Protocol Number: 13-009513
About this study
The study defines a new model of prenatal care called OB Nest which will be compared to the traditional model of prenatal care. 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. The goal of the project is to promote patient-centered care through a new prenatal care program based on constant and direct support from a nursing team, meeting the on-demand needs of expecting mothers as they rise, and as thus, redesigning the need and timing of on-site appointment with providers. Pregnant women randomized to the OB Nest cohort will see the number of pre-planned visits with their providers decreased and replaced with more direct and constant support and interaction with an assigned nursing team.
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
- 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)
- Clinical judgment that determines that the pregnancy is at high risk for complications.
- Any of the following high risk factors would disqualify the mother for the study:
- 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
- Inflammatory bowel disease
- Asthma and currently on steroid to control disease
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.