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| Name | Class |
|---|---|
| Baylor Health Care System | OTHER |
| Women's Clinic Shoals | UNKNOWN |
| Gainesville Obstetrics & Gynecology | OTHER |
| Womens Health Associates |
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This study is a multi-site, retrospective chart review to determine the effect of Neevo® or Neevo®DHA (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 Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm #1 (Test group) | 50 subjects administered Neevo® or Neevo®DHA daily |
| |
| Arm #2 (Control group) | 50 subjects administered a prenatal vitamin daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neevo® (a medical food) | Other |
| ||
| Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of Neevo®/Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin levels in pregnant women throughout the course of pregnancy. | At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of Neevo®/Neevo®DHA versus standard prenatal vitamins on red blood cell (RBC) levels in pregnant women. | At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. | |
| To determine if Neevo®/Neevo®DHA administration during pregnancy results in fewer anemias than with standard prenatal vitamins. |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin
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| Name | Affiliation | Role |
|---|---|---|
| Susan Bentley, CRNP | Women's Clinic Shoals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Clinic Shoals | Sheffield | Alabama | 35660 | United States | ||
| Women's Health Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21440300 | Result | 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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| UNKNOWN |
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| Other |
|
| At the time of diagnosis of pregnancy, at Weeks 22-28, and at delivery. |
| Flowood |
| Mississippi |
| 39232 |
| United States |
| Gainesville Obstetrics & Gynecology | Gainesville | Texas | 76240 | United States |
| 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 |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011295 | Prenatal Care |
| D005492 | Folic Acid |
| D007501 | Iron |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D008427 | Maternal Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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