Iron Parameters in Non-anemic First Trimester Gravidas

• Sponsor: Auerbach Hematology Oncology Associates P C (Other)
• Overall Status: Completed
• CT.gov ID: NCT03670537
• Collaborator: MedStar Women's Care at Honeygo (Other)
• Enrollment: 102
• Location: 1
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency (Without Anemia); Pregnancy	Diagnostic Test: Iron parameters

Detailed Description

The 2015 United States Preventive Services Task Force (USPSTF) stated "there is insufficient evidence to recommend the routine screening for iron deficiency in non-anemic gravidas". The basis for this recommendation is the lack maternal or fetal outcome data in this population. To date, there are no guidelines for the treatment of non-anemic, iron deficiency pregnancy women with or without anemia. Obstetricians and gynecologists often do not screen for iron deficiency unless the mean corpuscular volume (MCV) is reduced even in the presence of a reduced hemoglobin. Iron deficiency occurs prior to a decrement in hemoglobin concentration, followed by a decrease in the MCV which occurs after. Subsequently, if these recommendation are followed up to 50% of iron deficient pregnant women remain undiagnosed.

While prospective studies may be absent proving that routine screening and supplementation is beneficial, there is ample evidence that iron deficiency in mothers and infants results in significant morbidity, even in the absence of anemia. Fetal, neonatal and childhood brain growth and development require iron, with deficiencies resulting with adverse effects on myelination, neurotransmitter synthesis and brain programming. There is a two-fold incidence of preterm birth, three-fold increase in low birth weight and small for gestational age infants. In addition to negative effects on the fetus, maternal iron deficiency is associated with an increased risk for caesarean delivery, transfusion, perinatal bleeding, pre-eclampsia, placental abruption, poor wound healing, cardiac failure and even death. Of note, using existing guidelines infants are not screened for iron deficiency even if they are at high risk (preterm, infants of diabetic mothers, smokers or those with intrauterine growth restriction.

Published evidence suggests that when iron deficiency is present later in pregnancy in the mother, adequate iron delivery to the fetus does not occur. In a prospective study of 2400 urban women with iron deficiency in the second and third trimesters, while supplementation resulted in a significant improvement in maternal hemoglobin concentrations and iron parameters, over 45% of infants were iron deficient at birth.

Subsequently, while prospective studies are lacking supporting routine screening and iron supplementation, high quality published evidence imputing a litany of morbid events associated with iron deficiency, calls into question the recommendations of the USPSTF. Until such evidence is available based on the preponderance of evidence supporting absence of harm with either screening or supplementation we believe all gravidas presenting to their obstetricians should be screened for iron deficiency.

We propose a prospective observation study of one hundred consecutive, non-selected, non-anemic, first trimester pregnant women to have iron parameters added to their routine laboratory tests. While we realize this is not standard, many practices already have adopted this screening process. We intend to redact all demographic patient information and expect to incur no uncovered costs. As a result we believe neither investigational review board or informed consent is necessary. In hundreds of patients so screened we have encountered no insurance pushback. The additional tests will include only serum iron, total iron binding capacity (TIBC), percent transferrin saturation (Fe/TIBC) and serum ferritin. The data will be stratified by parity.

We anticipate to find an incidence of iron deficiency of 30-40% based on either a low TSAT or low serum ferritin. Such a finding should motivate properly powered, prospective outcome analyses supporting a new paradigm that incorporating the low cost screening for iron deficiency accompany standard screening tests at the beginning of pregnancy irrespective of the presence or absence of anemia.

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Iron Parameters in Non-anemic First Trimester Gravidas
• Actual Study Start Date: Feb 7, 2018
• Actual Primary Completion Date: Aug 24, 2018
• Actual Study Completion Date: Aug 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
First trimester pregnant women	Diagnostic Test: Iron parameters; Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin

Outcome Measures

Primary Outcome Measures

1. Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity [Day 1 presentation to obstetrician]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant in first trimester

• Non-anemic

Exclusion Criteria:

• anemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auerbach Hematology and Oncology	Baltimore	Maryland	United States	21237

Sponsors and Collaborators

• Auerbach Hematology Oncology Associates P C
• MedStar Women's Care at Honeygo

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 11, 2018

More Information

Publications

None provided.

• Responsible Party: Michael Auerbach MD, President and Clinical Professor of Medicine, Georgetown, Auerbach Hematology Oncology Associates P C
• ClinicalTrials.gov Identifier: NCT03670537
• Other Study ID Numbers: Protocol 3
• First Posted: Sep 13, 2018
• Last Update Posted: Jun 26, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Auerbach MD, President and Clinical Professor of Medicine, Georgetown, Auerbach Hematology Oncology Associates P C: Iron deficiency, Non-anemic; Pregnancy
• Additional relevant MeSH terms: Anemia, Iron-Deficiency

Study Results

Participant Flow

Arm/Group Title	First Trimester Pregnant Women
Arm/Group Description	Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Period Title: Overall Study
STARTED	102
COMPLETED	101
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	First Trimester Pregnant Women
Arm/Group Description	Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Overall Participants	101
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	101 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	101 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	101 100%
Gravidity (number of pregnancies) (Count of Participants)
Gravida 1	29 28.7%
Gravida 2	30 29.7%
Gravida 3	23 22.8%
Gravida 4	11 10.9%
Gravida 5	6 5.9%
Gravida 6 or more	2 2%

Outcome Measures

1. Primary Outcome

Title	Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
Description	Either low serum ferritin or low percent transferrin saturation (TSAT)
Time Frame	Day 1 presentation to obstetrician

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	First Trimester Pregnant Women
Arm/Group Description	Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
Measure Participants	101
Serum ferritin 25-30ng/ml	9 8.9%
Serum ferritin 20-25ng/ml	3 3%
Serum ferritin <20ng/ml	6 5.9%
TSAT <19%	38 37.6%

Adverse Events

Time Frame	During blood draw
Arm/Group Title	First Trimester Pregnant Women
Arm/Group Description	Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
All Cause Mortality
	First Trimester Pregnant Women
	Affected / at Risk (%)	# Events
Total	0/102 (0%)
Serious Adverse Events
	First Trimester Pregnant Women
	Affected / at Risk (%)	# Events
Total	0/102 (0%)
Other (Not Including Serious) Adverse Events
	First Trimester Pregnant Women
	Affected / at Risk (%)	# Events
Total	0/102 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.