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

NCT01193192 | Terminated

• 1 other identifier: N-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Anemia in Pregnancy; Pre-eclampsia

Keywords

Neevo; Neevo DHA; L-methylfolate; anemia during pregnancy; folic acid; vitamin B12; prenatal vitamins; hemoglobin; iron deficiency; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Arm #1 (Test Group)

100 subject administered Neevo® or NeevoDHA® daily

Other: Neevo®

Arm #2 (Control group)

100 subject administered a prenatal vitamin daily

Other: Prenatal vitamins

Interventions

Neevo® OTHER

A prenatal "medical food" - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid

Arm #1 (Test Group)

Prenatal vitamins OTHER

for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.

Arm #2 (Control group)

Eligibility Criteria

• Age: 21 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant Women Who Received Neevo®/NeevoDHA® or Another Standard Prenatal Vitamin

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamlab, L.L.C.: lead
• Baylor Health Care System: collaborator
• Norman Regional Health System: collaborator
• Five Oaks Medical Group: collaborator

Study Sites (3)

Five Oaks Medical Group

Chickasha, Oklahoma, 73018, United States

Location

Norman Regional Health System

Norman, Oklahoma, 73071, United States

Location

Norman Regional Health System

Norman, Oklahoma, 73072, United States

Location

Related Publications (1)

• 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.

  PMID: 21440300 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Iron Deficiencies

Interventions

Prenatal Care

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole Jarvis, M.D.

  Norman Regional Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

US (3)