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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anemia in Pregnancy, Pre-eclampsia

Intervention / Treatment
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* Other: Neevo®
* Other: Prenatal vitamins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm #1 (Test Group)<br>100 subject administered Neevo® or NeevoDHA® daily | Other: Neevo®<br>* A prenatal medical food - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid<br>|
| Arm #2 (Control group)<br>100 subject administered a prenatal vitamin daily | Other: Prenatal vitamins<br>* for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hemoglobin (Hgb) Levels | To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean change in hemoglobin levels in pregnant women. | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | 
| Incidence of Anemia | To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer incidences of anemia than with standard prenatal vitamins. | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | 
| Incidence of Pre-eclampsia | To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer cases of pre-eclampsia than with standard prenatal vitamins. | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | 
| Mean Infant Birth Rate | To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on infant birth weight. | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neevo, Neevo DHA, L-methylfolate, anemia during pregnancy, folic acid, vitamin B12, prenatal vitamins, hemoglobin, iron deficiency, Pregnancy