Ferritin as a Predictor for Anemia in Pregnancy

NCT03565198 | Unknown

• 1 other identifier: 17-366
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Anemia is a common problem with pregnant women around the world. There are high rates even within industrialized nations. The main cause of anemia in pregnancy is a lack of iron. There have been medical programs that give iron vitamins to all pregnant patients at the beginning of care to decrease anemia. These programs did not adequately decrease anemia in pregnancy. Many of them gave iron vitamins in doses that were low because pregnant patients sometimes have side effects to it. The next idea was to figure out which women were more at risk to get anemia and then treat them with a higher amount of iron. There are different blood tests to see how much iron stores are in the blood, but many do not work well during pregnancy. The test study staff think is the best for this is ferritin. The goal of this first small study is to see if healthcare providers can use the level of ferritin to predict anemia in pregnancy. This would then help to better screen, diagnose, and treat anemia during pregnancy. Study staff will enroll obstetric patients from the Women's Medicine Center and compare ferritin levels in these patients early in pregnancy with diagnosis of anemia later in pregnancy.

Conditions

Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• clinical anemia

  hemoglobin \< 11 mg/dL

  28 weeks gestation

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled through hospital's obstetric clinic.

You may qualify if:

• Age 15-45 years old at intake
• Confirmed intrauterine pregnancy by 1st trimester ultrasound

You may not qualify if:

• Antepartum iron supplementation, other than prenatal vitamins
• Placental abruption or hemorrhage
• Initial visit \>20 weeks gestation
• Diagnosis of sickle cell disease or thalassemia
• Diagnosed with anemia at initial prenatal visit
• Diagnosis of autoimmune issues that could effect iron levels

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25302, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2.5 mL aliquots of serum

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul Dietz, MD

  CAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dara Seybold, MAA

CONTACT

304-388-9922; djseybold@camc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 21, 2018
• Study Start: August 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: October 15, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)