Implementation and Evaluation of the OB Nest Project at the Point of Care: Redefining Continuity of Care for Expectant Mothers.

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

OB Nest is a model designed to promote increased patient-centered care during pregnancy. OB Nest care will allow for more flexibility, decrease interruptions to your productivity, while continuing to maintain safety for you and your infant. This model of care is anticipated to allow you more access to your health care team during your pregnancy. This study will compare OB Nest, a new model of prenatal care, to the existing traditional model of prenatal care. The plan is to have about 300 low-risk mothers take part in this study. Eligible patients will be randomized to one of two groups; The Traditional Prenatal care Group or the OB Nest Group. Mothers will have an equal chance of being assigned to the OB Nest group. Mothers randomized to the OB Nest intervention will be assigned to a nursing care team comprised of one to three nurses and see their initial eleven planned appointments with their provider reduced to six. Mothers will still be able to request additional in-office visits with their provider and/or the provider require additional in-office visits to monitor mother and infants safety/care.

Who is eligible to participate?

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 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 - HIV - Inflammatory bowel disease - Asthma and currently on steroid to control disease

Last updated:

3/6/2014

NCT ID:

NCT02082275

IRB Number:

13-009513