Anemia in Pregnancy, Pre-eclampsia
Conditions
Keywords
Neevo, Neevo DHA, L-methylfolate, anemia during pregnancy, folic acid, vitamin B12, prenatal vitamins, hemoglobin, iron deficiency, Pregnancy
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.
Interventions
OTHERNeevo®
A prenatal medical food - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid
OTHERPrenatal vitamins
for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.
Sponsors
Baylor Health Care System
Norman Regional Health System
Five Oaks Medical Group
Pamlab, L.L.C.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin (Hgb) Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | To determine the effect of Neevo®/NeevoDHA® versus standard prenatal vitamins on mean change in hemoglobin levels in pregnant women. |
| Incidence of Anemia | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer incidences of anemia than with standard prenatal vitamins. |
| Incidence of Pre-eclampsia | At the time of diagnosis of pregnancy, at the end of the second trimester (Weeks 22-28), and at delivery. | To determine if Neevo®/NeevoDHA® administration during pregnancy results in fewer cases of pre-eclampsia than with standard prenatal vitamins. |
| Mean Infant Birth Rate | 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 infant birth weight. |
Countries
United States
Outcome results
None listed