Status:
TERMINATED
A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Lead Sponsor:
Pamlab, L.L.C.
Collaborating Sponsors:
Baylor Health Care System
Norman Regional Health System
Conditions:
Anemia in Pregnancy
Pre-eclampsia
Eligibility:
FEMALE
21-39 years
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 pregn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01193192
Start Date
July 1 2010
End Date
November 1 2010
Last Update
November 23 2011
Active Locations (3)
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1
Five Oaks Medical Group
Chickasha, Oklahoma, United States, 73018
2
Norman Regional Health System
Norman, Oklahoma, United States, 73071
3
Norman Regional Health System
Norman, Oklahoma, United States, 73072