Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation

NCT07485023 | Not Yet Recruiting

• 1 other identifier: PRAN-0001
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to address this evidence gap by comparing a step-up oral-first strategy with an early IV iron strategy in pregnant women diagnosed with anemia after 34 weeks of gestation.

Conditions

Anemia Complicating Pregnancy

Outcome Measures

Primary Outcomes (1)

• Hemoglobin concentration (g/dL) measured at hospital admission for delivery.

  Delivery Hospitalization Day 1

Secondary Outcomes (8)

• Hemoglobin concentration (g/dL) at 38+0 weeks of gestation

  At 38+0 weeks of gestation

• Postpartum hemoglobin concentration (g/dL)

  Postpartum Day 1

• Absolute change in hemoglobin

  At delivery hospitalization

• Peripartum Blood Transfusion

  Peripeocedural

• Postpartum Anemia

  Periprocedural

Study Arms (2)

Oral Iron Supplementation

EXPERIMENTAL

Participants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations. Patients will undergo hematologic reassessment at 38+0 weeks of gestation: * If Hb ≥11 g/dL, oral iron will be continued. * If Hb \<11 g/dL, IV iron will be administered according to standard protocols, as a safety net.

Drug: Oral iron supplementation

IV Iron

ACTIVE COMPARATOR

Participants randomized to this group will receive IV iron within 7 days of diagnosis. The dose will be calculated based on body weight and estimated iron deficit. Oral iron supplementation is not mandated following IV administration.

Drug: IV iron administration

Interventions

Oral iron supplementation DRUG

Participants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations

Oral Iron Supplementation

IV iron administration DRUG

Participants randomized to this group will receive IV iron within 7 days of diagnosis. The dose will be calculated based on body weight and estimated iron deficit. Oral iron supplementation is not mandated following IV administration.

IV Iron

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 years or older.
• Singleton pregnancy.
• Gestational age ≥34+0 weeks at the time of anemia diagnosis.
• Hemoglobin \<11 g/dL measured as part of routine antenatal care.
• Ongoing antenatal follow-up at Policlinico Umberto I.
• Ability to understand study procedures and provide written informed consent.

You may not qualify if:

• Known anemia not primarily due to iron deficiency.
• Known hemoglobinopathies.
• Severe anemia requiring immediate blood transfusion.
• Previous severe hypersensitivity reaction to IV iron formulations.
• Chronic hematologic disease.
• Acute infection or inflammatory condition at enrollment.
• Severe hepatic or renal impairment.
• Any condition judged by the investigator to make participation unsafe.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Central Study Contacts

Giuseppe Rizzo, MD

CONTACT

+393386973001; giuseppe.rizzo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share