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

Pamlab

Status: Terminated

Conditions: Pregnancy

Treatments: Other: Néevo®/ NéevoDHA®

Study type: Observational

Funder types: Industry

Identifiers

NCT01358552

N-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

53 participants in 1 patient group

Néevo®/NéevoDHA®

Description:

Subjects who have been prescribed Néevo/NéevoDHA® daily.

Treatment:

Other: Néevo®/ NéevoDHA®