NCT03670537

Brief Summary

The purpose of the study is to see the percentage of non-anemic, first trimester gravidas presenting to their obstetricians, who are iron deficient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
1 month until next milestone

Results Posted

Study results publicly available

October 15, 2018

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

September 12, 2018

Results QC Date

October 10, 2018

Last Update Submit

June 25, 2019

Conditions

Iron Deficiency (Without Anemia)Pregnancy

Keywords

Iron deficiency, Non-anemicPregnancy

Outcome Measures

Primary Outcomes (1)

  • Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity

    Either low serum ferritin or low percent transferrin saturation (TSAT)

    Day 1 presentation to obstetrician

Study Arms (1)

First trimester pregnant women

Diagnostic Test: Iron parameters

Interventions

Iron parametersDIAGNOSTIC_TEST

Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin

First trimester pregnant women

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women presenting to their obstetricians

You may qualify if:

  • Pregnant in first trimester
  • Non-anemic

You may not qualify if:

  • anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auerbach Hematology and Oncology

Baltimore, Maryland, 21237, United States

Location

Related Publications (1)

  • Auerbach M, Abernathy J, Juul S, Short V, Derman R. Prevalence of iron deficiency in first trimester, nonanemic pregnant women. J Matern Fetal Neonatal Med. 2021 Mar;34(6):1002-1005. doi: 10.1080/14767058.2019.1619690. Epub 2019 Jun 3.

    PMID: 31154873RESULT

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Michael Auerbach
Organization
Auerbach Hematology and Oncology
mauerbachmd@abhemonc.com
4107804050

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President and Clinical Professor of Medicine, Georgetown

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

February 7, 2018

Primary Completion

August 24, 2018

Study Completion

August 24, 2018

Last Updated

June 26, 2019

Results First Posted

October 15, 2018

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)