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PregnancyNCT02082275

OB Nest; Redefining Continuity of Care for Expectant Mothers

A study testing OB Nest in people with Pregnancy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
OB Nest
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Feb 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Implementation and Evaluation of the OB Nest Project at the Point of Care: 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.

Read the 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.

Conditions
Pregnancy
Being tested
OB Nest
Keywords
Prenatal Care, Obstetrics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OB NestOther

    • 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.
Study groups in NCT02082275
Study groupRoleWhat they receive
OB NestExperimentalOB 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.
Receives: Other: OB Nest
Traditional Prenatal careNo interventionTraditional prenatal visits in clinic with OB providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expectant mothers satisfaction of prenatal care

    At 36 weeks the expectant mother will complete a survey that assessed their satisfaction of the prenatal care received using a validated scale.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionOct 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02082275
Sponsor's protocol ID
13-009513
Status last verified
Jan 2016
First submitted
6 Mar 2014
Last updated
8 Jan 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 33478433

  • 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.

    PubMed 31228414

  • 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.

    PubMed 26631000

Questions about this trial

What is this clinical trial studying?

A study testing OB Nest in people with Pregnancy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expectant mothers satisfaction of prenatal care (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02082275, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.

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