Pregnancy
Conditions
Keywords
Neevo, Neevo DHA, L-methylfolate, anemia during pregnancy, folic acid, vitamin B12, prenatal vitamins, hemoglobin, iron deficiency, Pregnancy
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.
Interventions
OTHERNéevo®/ 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.
Sponsors
InfoMedics, Inc.
Pamlab, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance | Week 4 | To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a real world setting. |
Secondary
| Measure | Time frame |
|---|---|
| To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale | Week 4 |
Countries
United States
Outcome results
None listed