OB Nest; Redefining Continuity of Care for Expectant Mothers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for 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 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

Treatment and study plan

OB Nest

Other

Reduction in the number of clinic office visits
Assignment to a specific nursing care team
Support and direct interaction available through tools which supports mom's empowerment to address her concerns, care for herself and connect with OB as necessary between clinic visits.
Empower and enable mothers to complete at home measurements for fetal heart rate, weight, and blood pressures.
Augmentation of in-person visits between care providers and patients with video conversations.
Maternal outcomes will be monitored through surveys and questionnaires.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 10, 2014
Registry last updated: Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed