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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Néevo®/ NéevoDHA®


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Néevo®/NéevoDHA®<br>Subjects who have been prescribed Néevo/NéevoDHA® daily. | Other: Néevo®/ NéevoDHA®<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance | To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a real world setting. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale |  | Week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neevo, Neevo DHA, L-methylfolate, anemia during pregnancy, folic acid, vitamin B12, prenatal vitamins, hemoglobin, iron deficiency, Pregnancy