Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Oral iron supplementation, IV iron administration.
- Кому может быть актуально
- Состояния в реестре: Anemia Complicating Pregnancy. Базовые параметры: 18 лет — 50 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат 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 - Препарат 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.
Первичные конечные точки
- Hemoglobin concentration (g/dL) measured at hospital admission for delivery. [Срок оценки: Delivery Hospitalization Day 1]
Вторичные конечные точки (8)
- Hemoglobin concentration (g/dL) at 38+0 weeks of gestation [Срок оценки: At 38+0 weeks of gestation]
- Postpartum hemoglobin concentration (g/dL) [Срок оценки: Postpartum Day 1]
- Absolute change in hemoglobin [Срок оценки: At delivery hospitalization]
- Peripartum Blood Transfusion [Срок оценки: Peripeocedural]
- Postpartum Anemia [Срок оценки: Periprocedural]
- Quantitatively Assessed Blood Loss [Срок оценки: Periprocedural]
- Lenght of Hospital Stay (days) [Срок оценки: Periprocedural]
- Adverse Event associated with Iron Supplementation [Срок оценки: Periprocedural]
Критерии участия
Критерии включения
- • 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.
Критерии исключения
- • 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07485023 · PRAN-0001