NCT07814378

Brief Summary

During pregnancy, iron deficiency is the most common cause of anemia. Anemia is very common during pregnancy and after childbirth. Around half of pregnant women develop anemia, and after delivery, up to 85% of women may be affected. This study looks at whether iron given through a vein (intravenous iron) can improve blood levels and how women feel and function in everyday life before and after giving birth.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Oct 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

PregancyIron deficiencyAnemia

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving an increase in hemoglobin concentration of ≥1 g/dL

    Proportion of patients with an increase in hemoglobin concentration of ≥1 g/dL from before the first intravenous iron administration to the last available measurement before delivery

    between iron supplementation and follow-up: 2-4 weeks

Interventions

IronDRUG

Iron supplementation will be performed according to Hamza et al., Recommendations of the AGG (Obstetrics Working Group, Section for Maternal Diseases) for the Management of Anemia in Pregnancy - Part 1 (Iron Deficiency Anemia) (https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-2628-7308.pdf)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

anemia walk-in clinic

You may qualify if:

  • Pregnancy

You may not qualify if:

  • Thalassemia
  • Sickle cell disease
  • Aplastic anemia
  • Hemochromatosis
  • Chronic inflammatory diseases associated with anemia of chronic disease
  • Severe renal insufficiency
  • Intravenous iron administration within 3 months prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Frankfurt, Department for Anaesthesiolgy, Intensive Care, and Pain Therapy

Frankfurt, Germany

Location

University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine

Würzburg, Germany

Location

MeSH Terms

Conditions

AnemiaIron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 11, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 11, 2026

Record last verified: 2026-09

Locations