Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-03-31

Brief Summary

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This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA® are invited to participate in surveys about their pregnancy and experiences with Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with personalized education and support during their pregnancies, and contribute to the overall understanding of the needs and concerns of women facing intermediate- to high-risk pregnancies.

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Detailed Description

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Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Néevo®/NéevoDHA® has been prescribed and provide them with a patient brochure containing an introduction to the program and instructions on how to enroll. Patients interested in participating self-enroll, take a brief survey before starting their Néevo®/NéevoDHA® prescription, and then a follow-up survey 4 weeks after they have started taking Néevo®/NéevoDHA®. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Néevo®/NéevoDHA® as directed. Patients will also receive educational materials about diet and nutrition during pregnancy.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Néevo®/NéevoDHA®

Subjects who have been prescribed Néevo/NéevoDHA® daily.

Néevo®/ NéevoDHA®

Intervention Type OTHER

Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.

Interventions

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Néevo®/ NéevoDHA®

Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* New Néevo®/NéevoDHA® Start.
* Only for women who are pregnant and taking brand name Néevo®/ NéevoDHA® under a physicians care.

Exclusion Criteria

* Patients who are not pregnant.
* If participant indicates that she did not get a prescription for Néevo®/ NéevoDHA®, she will not be able to complete the survey(s).
* For the follow-up survey, if the participant indicates that she has not been taking Néevo®/NéevoDHA®, she will not be able to complete the survey( (s).

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes