A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Mean Hemoglobin (Hgb) Levels
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 21 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Mean Hemoglobin (Hgb) Levels
Time Frame: At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.
To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean hemoglobin (Hgb) levels in pregnant women throughout the course of pregnancy.
Secondary Outcomes
- Mean Change in Hemoglobin (Hgb) Levels(At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.)
- Incidence of Anemia(At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.)
- Incidence of Pre-eclampsia(At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.)
- Mean Infant Birth Rate(At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery.)