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Inadequate number of charts available for Test Group
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| Name | Class |
|---|---|
| Baylor Health Care System | OTHER |
| Norman Regional Health System | UNKNOWN |
| Five Oaks Medical Group | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm #1 (Test Group) | 100 subject administered Neevo® or NeevoDHA® daily |
| |
| Arm #2 (Control group) | 100 subject administered a prenatal vitamin daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neevo® | Other | A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant Women Who Received Neevo®/NeevoDHA® or Another Standard Prenatal Vitamin
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Jarvis, M.D. | Norman Regional Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Five Oaks Medical Group | Chickasha | Oklahoma | 73018 | United States | ||
| Norman Regional Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21440300 | Derived | Bentley S, Hermes A, Phillips D, Daoud YA, Hanna S. Comparative effectiveness of a prenatal medical food to prenatal vitamins on hemoglobin levels and adverse outcomes: a retrospective analysis. Clin Ther. 2011 Feb;33(2):204-10. doi: 10.1016/j.clinthera.2011.02.010. Epub 2011 Mar 25. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011295 | Prenatal Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D008427 | Maternal Health Services |
| D003153 | Community Health Services |
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| Prenatal vitamins | Other | for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12. |
|
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. |
| Norman |
| Oklahoma |
| 73071 |
| United States |
| Norman Regional Health System | Norman | Oklahoma | 73072 | United States |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |