Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Correction of anemia
研究概览
简要总结
Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion.
The goal of this clinical trial:
- Correct IDA with fewer visits and less impact on the healthcare system
- Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.
详细描述
IDA is associated with poor neonatal outcomes and maternal morbidity. This clinical trial will compare IV iron isomaltoside to IV iron sucrose for correction of IDA, along with the potential impacts to the patient: physical, emotional and convenience. The study will also take into consideration the financial and resource impacts to the healthcare system, as well as determine the validity of using iron isomaltoside in second and third trimester pregnancy.
The trial will be a randomized, comparative, single center, phase III trial with a 1:1 allocation ratio. There will be two groups involved in this trial. Group 1: A single dose of IV iron isomaltoside. Group 2: Standard iron sucrose therapy.
Eligible participants will be screened for IDA during the initial appointment (greater or equal to 13 weeks gestational age) with the obstetrical care provider. Discussion/awareness about the study will be discussed at their appointment or over the telephone with the obstetrical care provider. This information will only be discussed if the patient requires IV iron repletion in second or third trimester pregnancy.
Enrollment inclusion/exclusion criteria must be met for the participant to receive the information about the study.
Study personnel will discuss the clinical trial, including obtaining informed consent with the eligible participant. Baseline vital signs and blood work will be documented from the previous patient visit where IDA was diagnosed. Documentation and data collection will occur at 3 other points within the clinical trial: Post iron infusion (approximately 30 days after infusion), during delivery and at 6 weeks postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and over
- •Pregnancy with Gestational age ≥13 weeks
- •Iron deficiency anemia defined as:
- •Hemoglobin less than or equal to 110g/L and
- •Serum ferritin less than 30ng/mL or
- •Iron Saturation (Iron/TIBC) less than 20%
- •Willing to participate and attend all planned follow up visits
- •Willing to sign informed consent form
- •Willing to attend appointments for iron infusion and follow up visits
- •Willing to attend all planned bloodwork appointments
排除标准
- •Pregnancy GA less than 13 weeks
- •History of anemia caused by thalassemia or other haematologic disorder other than iron deficiency anemia ,
- •Known serious hypersensitivity to other parental iron products
- •Iron overload or disturbances in utilization of iron (i.e, haemochromatosis and haemosiderosis)
- •Decompensated liver cirrhosis or active hepatitis
- •History of multiple allergies
- •Active acute or chronic infections
- •Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
- •Current participation in any other interventional trial
- •Multiple gestation pregnancy
- •Significant comorbidities (asthma requiring daily therapy or other lung diseases)
- •Heart disease
- •Kidney disease
- •Rheumatologic disease
- •Known hypersensitivity to iron sucrose or any excipients
- •Known hypersensitivity to iron isomaltoside or any excipients.
研究组 & 干预措施
Iron Isomaltoside/ferric derisomaltose
route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)
干预措施: Iron Isomaltoside 1000, ferric derisomaltose (Drug)
Iron Sucrose
Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table
干预措施: Iron sucrose (Drug)
结局指标
主要结局
Correction of anemia
时间窗: 6 week post partum visit
defined as (hemoglobin) hgb greater or equal to 110 g/L (grams per litre), all participants
次要结局
- Comparison of participant's pregnancy related symptoms- subjective measure(collected from baseline, at delivery and 6 weeks postpartum)
- Convenience/barriers of IV iron appointment(s)- subjective measure(collected at delivery admission, post iron infusion)
- Changes in Participant's Mental Health and Physical Well-Being(baseline (at intake), post iron infusion (1 week after infusion), at delivery, at 6 weeks post partum)
- Reported bonding with baby-subjective(collected at 6 weeks postpartum)
- Participant's tolerance to IV iron infusion(Collected at delivery admission survey)
研究者
Ryan Lett
Physician Lead Patient Blood Management Department
Saskatchewan Health Authority - Regina Area