Clinical trial NCT01358552: Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)
Official title: Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Keywords: Neevo
Neevo DHA
L-methylfolate
anemia during pregnancy
folic acid
vitamin B12
prenatal vitamins
hemoglobin
iron deficiency
Pregnancy
Lead sponsor: Pamlab, Inc.
Sponsor class: INDUSTRY
Collaborators: name: InfoMedics, Inc.
First posted: 2011-05-23
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have been prescribed Néevo®/ NéevoDHA®

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.

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).

Primary outcomes:
measure: To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance
timeFrame: Week 4
Secondary outcomes:
measure: To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale
timeFrame: Week 4
Other outcomes:
Locations:
city: Corpus Christi
country: United States
facility: Noe Lira, M.D.
state: Texas
Study officials:
affiliation: Noe Lira, M.D.
name: Noe Lira, M.D.
role: PRINCIPAL_INVESTIGATOR
References: