- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082275
OB Nest; Redefining Continuity of Care for Expectant Mothers
Implementation and Evaluation of the OB Nest Project at the Point of Care: Redefining Continuity of Care for Expectant Mothers.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OB Nest
OB Nest is designed to reduce the number of pre-planned visits with their OB provider and replace the in-clinic visits with a direct and constant support from an assigned nursing team.
OB Nest will empower moms-to-be to take ownership of their prenatal care by providing a wealth of resources.
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No Intervention: Traditional Prenatal care
Traditional prenatal visits in clinic with OB providers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expectant mothers satisfaction of prenatal care
Time Frame: 36 weeks
|
At 36 weeks the expectant mother will complete a survey that assessed their satisfaction of the prenatal care received using a validated scale.
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36 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abimbola Famuyide, MBBS, Mayo Clinic
Publications and helpful links
General Publications
- Theiler RN, Butler-Tobah Y, Hathcock MA, Famuyide A. OB Nest randomized controlled trial: a cost comparison of reduced visit compared to traditional prenatal care. BMC Pregnancy Childbirth. 2021 Jan 21;21(1):71. doi: 10.1186/s12884-021-03557-3.
- Butler Tobah YS, LeBlanc A, Branda ME, Inselman JW, Morris MA, Ridgeway JL, Finnie DM, Theiler R, Torbenson VE, Brodrick EM, Meylor de Mooij M, Gostout B, Famuyide A. Randomized comparison of a reduced-visit prenatal care model enhanced with remote monitoring. Am J Obstet Gynecol. 2019 Dec;221(6):638.e1-638.e8. doi: 10.1016/j.ajog.2019.06.034. Epub 2019 Jun 19.
- Ridgeway JL, LeBlanc A, Branda M, Harms RW, Morris MA, Nesbitt K, Gostout BS, Barkey LM, Sobolewski SM, Brodrick E, Inselman J, Baron A, Sivly A, Baker M, Finnie D, Chaudhry R, Famuyide AO. Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study. BMC Pregnancy Childbirth. 2015 Dec 2;15:323. doi: 10.1186/s12884-015-0762-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 13-009513
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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