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

Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia Complicating Pregnancy
• Intervention / Treatment: Drug: Oral iron supplementation; Drug: IV iron administration

Detailed Description

Anemia during pregnancy remains a prevalent condition worldwide and is associated with a wide spectrum of adverse maternal and perinatal outcomes. Maternal anemia has been linked to increased risk of postpartum anemia, need for blood transfusion, impaired physical recovery after delivery, prolonged hospital stay, and reduced quality of life in the puerperium. From a healthcare system perspective, anemia management close to delivery has important implications for resource utilization and patient safety.

Recent National Guidelines have updated the diagnostic thresholds for anemia in pregnancy, defining anemia as hemoglobin (Hb) <11 g/dL throughout gestation, including the third trimester. As a result, a growing number of women are diagnosed with anemia late in pregnancy, often after 34 weeks of gestation, when the time window for hematologic correction before delivery is limited.

In this setting, intravenous (IV) iron therapy is increasingly used to achieve a rapid increase in hemoglobin levels. While IV iron is effective and generally safe, it is associated with higher costs, need for monitored administration, and a small but non-negligible risk of hypersensitivity reactions. Importantly, the routine early use of IV iron in women diagnosed late in pregnancy is not uniformly supported by high-quality randomized evidence.

Oral iron remains the recommended first-line therapy for iron-deficiency anemia in pregnancy. However, the effectiveness of oral iron when initiated in late gestation is often questioned, leading to premature escalation to IV therapy without a documented trial of oral treatment. There is limited prospective evidence assessing whether oral iron, when promptly initiated after late diagnosis, can still achieve clinically meaningful hemoglobin improvements before delivery.

A step-up treatment strategy, consisting of oral iron as initial therapy with escalation to IV iron only in case of inadequate response, may represent a balanced approach that aligns with guideline recommendations, minimizes overtreatment, and preserves patient safety. However, this strategy has not been adequately evaluated in randomized controlled trials focusing specifically on late-diagnosed anemia.

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Rizzo, MD; Phone Number: +393386973001; Email: giuseppe.rizzo@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Iron Supplementation; 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; Participants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations
Active Comparator: IV Iron; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin concentration (g/dL) measured at hospital admission for delivery.	Delivery Hospitalization Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Quantitatively Assessed Blood Loss	Periprocedural
Lenght of Hospital Stay (days)	Periprocedural
Adverse Event associated with Iron Supplementation	Periprocedural

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRAN-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No