A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy

N/ATerminatedNCT01193192

Pamlab, L.L.C.30 enrolled

Overview

This study is a multi-site, retrospective chart review to determine the effect of Neevo® or NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical food indicated for the dietary management of women under a doctor's care who face high risk pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize folic acid. Data will be collected from existing patient charts of subjects administered Neevo® or NeevoDHA® daily compared to subjects administered a prenatal vitamin daily.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anemia in Pregnancy Pre-eclampsia

Interventions

Neevo®OTHER

A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant females, age 21-39, who received either Neevo®/NeevoDHA® or another standard prenatal vitamin (Prenatal vitamins must contain ≤1 mg folic acid, 27-35mg iron, and ≤12mcg vitamin B12). * Clinical diagnosis of pregnancy must have been made at ≤12 weeks of Pregnancy, and delivery must have occurred on or after January 1, 2008 and on or before March 31, 2010 * Subjects must have been compliant in taking Neevo®/NeevoDHA® or other prenatal vitamin Exclusion Criteria: * Subjects should not have taken Prenate®, Prenate®DHA, or Prenate® Elite, which are L-methylfolate-containing prenatal vitamins. * The following supplements within 2 months of diagnosis of pregnancy: B12 injection; \> 35mg Iron; \> 1.2 mg of folate; or a L-methylfolate product that is not a prenatal vitamin such as Life Extension methylfolate, Prothera methylfolate, Thorne 5-MTHF, Metanx®, Deplin®, Cerefolin®, or CerefolinNAC® * History of leukemia or any anemia other than iron deficiency anemia or; * Taking any iron supplement (in addition to the prenatal vitamin) prior to Week 22

Locations (3)

Five Oaks Medical Group

Chickasha, Oklahoma, United States

Norman Regional Health System

Norman, Oklahoma, United States

Norman Regional Health System

Norman, Oklahoma, United States

Outcomes

Primary Outcomes

Mean Hemoglobin (Hgb) Levels

To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy.