Anemia Complicating PregnancyLAPISNCT07485023
Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation
A study testing Oral iron supplementation and IV iron administration in people with Anemia Complicating Pregnancy, run by University of Roma La Sapienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Anemia Complicating Pregnancy
- What is being tested?
- Oral iron supplementation and IV iron administration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia Complicating Pregnancy
- Being tested
- Oral iron supplementation, IV iron administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral iron supplementationDrug
Participants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations
IV iron administrationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: IV iron administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration (g/dL) measured at hospital admission for delivery.
Measured: Delivery Hospitalization Day 1
Secondary outcomes (8)
Hemoglobin concentration (g/dL) at 38+0 weeks of gestation
Measured: At 38+0 weeks of gestation
Postpartum hemoglobin concentration (g/dL)
Measured: Postpartum Day 1
Absolute change in hemoglobin
Measured: At delivery hospitalization
Peripartum Blood Transfusion
Measured: Peripeocedural
Postpartum Anemia
Measured: Periprocedural
Quantitatively Assessed Blood Loss
Measured: Periprocedural
Lenght of Hospital Stay (days)
Measured: Periprocedural
Adverse Event associated with Iron Supplementation
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Rizzo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485023
- Sponsor's protocol ID
- PRAN-0001
- Acronym
- LAPIS
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07485023
- Acronym / sponsor ID
- LAPIS / PRAN-0001
- Conditions
- Anemia Complicating Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Iron Supplementation | Experimental | Drug: Oral iron supplementationParticipants 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. |
| IV Iron | Active comparator | Drug: IV iron administrationParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Women aged 18 years or older.
Key exclusion criteria (8 listed)
- • Known anemia not primarily due to iron deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral iron supplementationParticipants randomized to this group will begin oral iron therapy immediately after diagnosis. The formulation and dosage will follow institutional practice and guideline recommendations | Drug | Oral Iron Supplementation |
| IV iron administrationParticipants 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 |
Primary outcome
Hemoglobin concentration (g/dL) measured at hospital admission for delivery.
Time frame: Delivery Hospitalization Day 1
8 secondary outcomes
Hemoglobin concentration (g/dL) at 38+0 weeks of gestation
Time frame: At 38+0 weeks of gestation
Postpartum hemoglobin concentration (g/dL)
Time frame: Postpartum Day 1
Absolute change in hemoglobin
Time frame: At delivery hospitalization
Peripartum Blood Transfusion
Time frame: Peripeocedural
Postpartum Anemia
Time frame: Periprocedural
Quantitatively Assessed Blood Loss
Time frame: Periprocedural
Lenght of Hospital Stay (days)
Time frame: Periprocedural
Adverse Event associated with Iron Supplementation
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Oral iron supplementation and IV iron administration in people with Anemia Complicating Pregnancy, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Rizzo, MD (+393386973001, giuseppe.rizzo@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration (g/dL) measured at hospital admission for delivery. (time frame: Delivery Hospitalization Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.