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

Pamlab

Status

Terminated

Conditions

Pre-eclampsia

Anemia in Pregnancy

Treatments

Other: Neevo®

Other: Prenatal vitamins

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01193192

N-002

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

21 to 39 years old

Volunteers

Accepts Healthy Volunteers

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