Iron Deficiency Anemia of PregnancyPhase 3IDANCT06366698
Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia
A Phase 3 study testing Venofer 200 MG Per 10 ML Injection and Ferrous sulfate in people with Iron Deficiency Anemia of Pregnancy, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Venofer 200 MG Per 10 ML Injection and Ferrous sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years of age
- Ferritin level < 30 ng/mL
- Singe gestation
- Gestational age up to 36 weeks as iron therapy after this has shown to be not beneficial at time of delivery. We will still plan to treat patients > 36 weeks but not include them in the final analysis
- Plan to delivery at Arrowhead Regional Medical Center (ARMC)
Who cannot join
- Maternal age < 18 years of age
- Incarcerated patients
- Multifetal gestation
- Acute liver/kidney disease
- Active infections
- Known hematological malignancy
Show all 9Show fewer
- Other causes of anemia such as alpha/beta thalassemia, sickle cell disease, Folate/B12 deficiency, and anemia of chronic diseases
- Known hypersensitivity with IV iron
- Severe symptoms of anemia requiring blood transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arrowhead Regional Medical Center
Colton, California, 92324
Guillermo Valenzuela, MD, 909-580-4145, jvalenzuelar@me.com
Tina M Bui, DO
About this study
Official title: Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy
This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.
Read the detailed description
Iron deficiency anemia is a prevalent health concern affecting approximately a quarter of the global population. In specific high-risk subgroups such as pregnancy, the occurrence of anemia is even higher. This condition is associated with adverse outcomes such as increased risks of blood transfusion, longer hospital stays, slower recovery, and depression, along with pregnancy risks such as preterm birth and low birth weight. Furthermore, infants born to iron-deficient mothers are at risk for delayed childhood growth and cognitive development. Preoperative optimization is crucial for improving clinical outcomes, as iron deficiency anemia accounts for over 80% of anemia cases in these patients.
Traditionally, oral (PO) iron supplementation has been the standard approach recommended by the American College of Obstetrics and Gynecology (ACOG) for preventing and addressing iron deficiency due to its simplicity and cost-effectiveness. However, it is marred by poor adherence to therapy and a high incidence of gastrointestinal side effects. While numerous publications have documented the safety and efficacy of intravenous (IV) iron, its utilization remains limited. Currently, IV iron is primarily reserved for patients who exhibit intolerance or an inadequate response to oral therapy. At our institution, we have taken proactive steps by administering IV iron infusions to many of our patients at an earlier gestational age, given the high rate of non-compliance with oral iron therapy. Our hypothesis proposes that individuals with iron deficiency anemia, defined as a serum ferritin level of less than 30 ng/mL (with 92% sensitivity and 98% specificity compared to hemoglobin (Hgb) levels), who receive IV iron infusions, will achieve higher Hgb levels upon admission and experience reduced rates of blood transfusions.
This study aims to assess the impact of IV iron infusions on pregnant patients with iron deficiency anemia. We hope that implementing this study will help improve overall population health. We hypothesize that individuals with iron deficiency anemia who receive IV iron infusions will attain higher Hgb levels at the time of admission and experience reduced rates of blood transfusions at the time of delivery.
After obtaining the patient's consent, they will be randomized into either of the two treatment options. All odd numbers will be in the oral iron group and even numbers enrolled into the IV iron group. We intend to administer Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water, as numerous randomized control trials have demonstrated that increasing the iron dose does not lead to improved efficacy. Venofer 200 mg will be given every other day until the patient reaches their calculated iron deficit. The dose of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg. Our target Hgb will be 11.0 g/dL.
Patients will be given a symptom questionnaire at the time of enrollment to fill out. We will analyze the patient's ferritin, iron, total iron binding capacity (TIBC), Hgb level, mean corpuscular volume (MCV), and Hgb electrophoresis, which are routinely obtained on the first visit with prenatal labs. Four weeks after initiating treatment, patients will fill out a symptom and side effect questionnaire, and if on PO iron, their compliance will be assessed. Complete blood count (CBC) and iron studies will be repeated at that time. Other patient information such as admission CBC, post-delivery CBC, height, weight, body mass index (BMI), age, parity, gestational age at delivery, quantitative blood loss, route of delivery, need for blood transfusion, number of IV iron infusions, fetal birth weight, and antepartum/intrapartum/postpartum complications such as diabetes, preeclampsia/eclampsia, chorioamnionitis, and hemorrhage, etc., neonatal intensive care unit (NICU) admission as well as Edinburgh depression screening results, will be obtained from medical records. This information will be used for secondary outcomes analysis and to ensure there are no confounding factors. Statistical comparisons between groups will be performed using the two-way T-test followed by Tukey's test, or post hoc Student-Newman-Keuls tests. A P < .05 will be considered a statistically significant difference among groups.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Venofer 200 MG Per 10 ML Injection, Ferrous sulfate
- Keywords
- Anemia, Iron deficiency, Pregnancy, Intravenous iron
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venofer 200 MG Per 10 ML InjectionDrug
Also called Iron sucrose
200 mg IV every 2 days until the targeted dose
Ferrous sulfateDrug
Take 1 tablet every other day with lemon/orange juice
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Active comparator | Venofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit. Receives: Drug: Venofer 200 MG Per 10 ML Injection |
| Oral iron | Placebo comparator | Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery. Receives: Drug: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin difference
Change in hemoglobin level after intervention, larger difference mean more improvement in Hgb
Measured: Hemoglobin level obtained prior to treatment and then 4 weeks later
Ferritin difference
Change in ferritin level after intervention, larger difference mean more improvement in ferritin level
Measured: Ferritin level obtained prior to treatment and then 4 weeks later
Delivery Hemoglobin
Comparing pre-delivery hemoglobin levels
Measured: Obtained at time of delivery
Rates of blood transfusion
Comparing rates of blood transfusion at time of delivery between the 2 groups. The number of units transfused will be collected and compared among the groups
Measured: At time of delivery until 6 weeks postpartum
Symptoms
Comparing number of anemia symptoms before and after treatment. There are 11 anemia symptoms on the questionnaire. Using a Likert scale from 0 (no symptoms) to 5 (severe symptoms) patient mark each one. The score is totaled up and can range from 0-55.
Measured: 4 weeks
Secondary outcomes (3)
Preterm delivery
Comparing hemoglobin levels to gestational age at delivery
Measured: At the time of delivery
Depression
Edinburgh postnatal depression scale at first prenatal visit and postpartum. 10 questions with total score between 0-30. Higher score indicated increase risk for depression.
Measured: Duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Birthweight
Comparing birthweight to hemoglobin levels at time of admission
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start21 Nov 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366698
- Sponsor's protocol ID
- 23-55
- Acronym
- IDA
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.
PubMed 26817624Anemia in Pregnancy: ACOG Practice Bulletin, Number 233. Obstet Gynecol. 2021 Aug 1;138(2):e55-e64. doi: 10.1097/AOG.0000000000004477.
PubMed 34293770Achebe MM, Gafter-Gvili A. How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood. 2017 Feb 23;129(8):940-949. doi: 10.1182/blood-2016-08-672246. Epub 2016 Dec 29.
PubMed 28034892Tigga MP, Debbarma AP. A comparative study to evaluate oral iron and intravenous iron sucrose for treatment of anemia in pregnancy in a poor socioeconomic region of Northeast India. Tzu Chi Med J. 2019 Jul 24;32(3):258-261. doi: 10.4103/tcmj.tcmj_99_19. eCollection 2020 Jul-Sep.
PubMed 32955516Chua S, Gupta S, Curnow J, Gidaszewski B, Khajehei M, Diplock H. Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial. BMC Pregnancy Childbirth. 2017 Dec 19;17(1):424. doi: 10.1186/s12884-017-1596-x.
PubMed 29258541Ng O, Keeler BD, Mishra A, Simpson JA, Neal K, Al-Hassi HO, Brookes MJ, Acheson AG. Iron therapy for preoperative anaemia. Cochrane Database Syst Rev. 2019 Dec 7;12(12):CD011588. doi: 10.1002/14651858.CD011588.pub3.
PubMed 31811820Nicholls G, Mehta R, McVeagh K, Egan M. The Effects of Intravenous Iron Infusion on Preoperative Hemoglobin Concentration in Iron Deficiency Anemia: Retrospective Observational Study. Interact J Med Res. 2022 Feb 3;11(1):e31082. doi: 10.2196/31082.
PubMed 35113024Lewkowitz AK, Stout MJ, Cooke E, Deoni SC, D'Sa V, Rouse DJ, Carter EB, Tuuli MG. Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial. Am J Perinatol. 2022 Jun;39(8):808-815. doi: 10.1055/s-0041-1740003. Epub 2021 Nov 28.
PubMed 34839481Wong L, Smith S, Gilstrop M, Derman R, Auerbach S, London N, Lenowitz S, Bahrain H, McClintock J, Auerbach M. Safety and efficacy of rapid (1,000 mg in 1 hr) intravenous iron dextran for treatment of maternal iron deficient anemia of pregnancy. Am J Hematol. 2016 Jun;91(6):590-3. doi: 10.1002/ajh.24361. Epub 2016 Apr 13.
PubMed 26971581Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.
PubMed 36107229Govindappagari S, Burwick RM. Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis. Am J Perinatol. 2019 Mar;36(4):366-376. doi: 10.1055/s-0038-1668555. Epub 2018 Aug 19.
PubMed 30121943Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
PubMed 31413088
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT06366698
- Acronym / sponsor ID
- IDA / 23-55
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Keywords
- Anemia, Iron deficiency, Pregnancy, Intravenous iron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (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 assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded.
Detailed description
Iron deficiency anemia is a prevalent health concern affecting approximately a quarter of the global population. In specific high-risk subgroups such as pregnancy, the occurrence of anemia is even higher. This condition is associated with adverse outcomes such as increased risks of blood transfusion, longer hospital stays, slower recovery, and depression, along with pregnancy risks such as preterm birth and low birth weight. Furthermore, infants born to iron-deficient mothers are at risk for delayed childhood growth and cognitive development. Preoperative optimization is crucial for improving clinical outcomes, as iron deficiency anemia accounts for over 80% of anemia cases in these patients.
Traditionally, oral (PO) iron supplementation has been the standard approach recommended by the American College of Obstetrics and Gynecology (ACOG) for preventing and addressing iron deficiency due to its simplicity and cost-effectiveness. However, it is marred by poor adherence to therapy and a high incidence of gastrointestinal side effects. While numerous publications have documented the safety and efficacy of intravenous (IV) iron, its utilization remains limited. Currently, IV iron is primarily reserved for patients who exhibit intolerance or an inadequate response to oral therapy. At our institution, we have taken proactive steps by administering IV iron infusions to many of our patients at an earlier gestational age, given the high rate of non-compliance with oral iron therapy. Our hypothesis proposes that individuals with iron deficiency anemia, defined as a serum ferritin level of less than 30 ng/mL (with 92% sensitivity and 98% specificity compared to hemoglobin (Hgb) levels), who receive IV iron infusions, will achieve higher Hgb levels upon admission and experience reduced rates of blood transfusions.
This study aims to assess the impact of IV iron infusions on pregnant patients with iron deficiency anemia. We hope that implementing this study will help improve overall population health. We hypothesize that individuals with iron deficiency anemia who receive IV iron infusions will attain higher Hgb levels at the time of admission and experience reduced rates of blood transfusions at the time of delivery.
After obtaining the patient's consent, they will be randomized into either of the two treatment options. All odd numbers will be in the oral iron group and even numbers enrolled into the IV iron group. We intend to administer Ferrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water, as numerous randomized control trials have demonstrated that increasing the iron dose does not lead to improved efficacy. Venofer 200 mg will be given every other day until the patient reaches their calculated iron deficit. The dose of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg. Our target Hgb will be 11.0 g/dL.
Patients will be given a symptom questionnaire at the time of enrollment to fill out. We will analyze the patient's ferritin, iron, total iron binding capacity (TIBC), Hgb level, mean corpuscular volume (MCV), and Hgb electrophoresis, which are routinely obtained on the first visit with prenatal labs. Four weeks after initiating treatment, patients will fill out a symptom and side effect questionnaire, and if on PO iron, their compliance will be assessed. Complete blood count (CBC) and iron studies will be repeated at that time. Other patient information such as admission CBC, post-delivery CBC, height, weight, body mass index (BMI), age, parity, gestational age at delivery, quantitative blood loss, route of delivery, need for blood transfusion, number of IV iron infusions, fetal birth weight, and antepartum/intrapartum/postpartum complications such as diabetes, preeclampsia/eclampsia, chorioamnionitis, and hemorrhage, etc., neonatal intensive care unit (NICU) admission as well as Edinburgh depression screening results, will be obtained from medical records. This information will be used for secondary outcomes analysis and to ensure there are no confounding factors. Statistical comparisons between groups will be performed using the two-way T-test followed by Tukey's test, or post hoc Student-Newman-Keuls tests. A P < .05 will be considered a statistically significant difference among groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia.
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Active comparator | Drug: Venofer 200 MG Per 10 ML InjectionVenofer 200 mg will be given every other day until the patient reaches their calculated in deficit dose. The does of IV iron will be calculated according to the Ganzoni formula: total iron dose (mg) = body weight (kg) x (target Hgb - baseline Hgb (g/dL)) × 0.24 + 500 mg.14 Our target Hgb will be 11.0 g/dL. The determination of the treatment duration and dosage will be based on the calculation of the iron deficit. |
| Oral iron | Placebo comparator | Drug: Ferrous sulfateFerrous sulfate 325 mg orally every other day on an empty stomach with lemon/orange water until delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Ferritin level < 30 ng/mL
- Singe gestation
- Gestational age up to 36 weeks as iron therapy after this has shown to be not beneficial at time of delivery. We will still plan to treat patients > 36 weeks but not include them in the final analysis
- Plan to delivery at Arrowhead Regional Medical Center (ARMC)
Key exclusion criteria (9 listed)
- Maternal age < 18 years of age
- Incarcerated patients
- Multifetal gestation
- Acute liver/kidney disease
- Active infections
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 |
|---|---|---|
| Venofer 200 MG Per 10 ML InjectionAlso: Iron sucrose200 mg IV every 2 days until the targeted dose | Drug | Intravenous iron |
| Ferrous sulfateTake 1 tablet every other day with lemon/orange juice | Drug | Oral iron |
Primary outcome
Hemoglobin difference
Time frame: Hemoglobin level obtained prior to treatment and then 4 weeks later
Change in hemoglobin level after intervention, larger difference mean more improvement in Hgb
Ferritin difference
Time frame: Ferritin level obtained prior to treatment and then 4 weeks later
Change in ferritin level after intervention, larger difference mean more improvement in ferritin level
Delivery Hemoglobin
Time frame: Obtained at time of delivery
Comparing pre-delivery hemoglobin levels
Rates of blood transfusion
Time frame: At time of delivery until 6 weeks postpartum
Comparing rates of blood transfusion at time of delivery between the 2 groups. The number of units transfused will be collected and compared among the groups
Symptoms
Time frame: 4 weeks
Comparing number of anemia symptoms before and after treatment. There are 11 anemia symptoms on the questionnaire. Using a Likert scale from 0 (no symptoms) to 5 (severe symptoms) patient mark each one. The score is totaled up and can range from 0-55.
3 secondary outcomes
Preterm delivery
Time frame: At the time of delivery
Depression
Time frame: Duration of the pregnancy (up to 40 weeks) and up to 2 months postpartum
Birthweight
Time frame: At time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 26817624Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.
- Background: PubMed 34293770Anemia in Pregnancy: ACOG Practice Bulletin, Number 233. Obstet Gynecol. 2021 Aug 1;138(2):e55-e64. doi: 10.1097/AOG.0000000000004477.
- Background: PubMed 28034892Achebe MM, Gafter-Gvili A. How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood. 2017 Feb 23;129(8):940-949. doi: 10.1182/blood-2016-08-672246. Epub 2016 Dec 29.
- Background: PubMed 32955516Tigga MP, Debbarma AP. A comparative study to evaluate oral iron and intravenous iron sucrose for treatment of anemia in pregnancy in a poor socioeconomic region of Northeast India. Tzu Chi Med J. 2019 Jul 24;32(3):258-261. doi: 10.4103/tcmj.tcmj_99_19. eCollection 2020 Jul-Sep.
- Background: PubMed 29258541Chua S, Gupta S, Curnow J, Gidaszewski B, Khajehei M, Diplock H. Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial. BMC Pregnancy Childbirth. 2017 Dec 19;17(1):424. doi: 10.1186/s12884-017-1596-x.
- Results publication: PubMed 31811820Ng O, Keeler BD, Mishra A, Simpson JA, Neal K, Al-Hassi HO, Brookes MJ, Acheson AG. Iron therapy for preoperative anaemia. Cochrane Database Syst Rev. 2019 Dec 7;12(12):CD011588. doi: 10.1002/14651858.CD011588.pub3.
- Results publication: PubMed 35113024Nicholls G, Mehta R, McVeagh K, Egan M. The Effects of Intravenous Iron Infusion on Preoperative Hemoglobin Concentration in Iron Deficiency Anemia: Retrospective Observational Study. Interact J Med Res. 2022 Feb 3;11(1):e31082. doi: 10.2196/31082.
- Results publication: PubMed 34839481Lewkowitz AK, Stout MJ, Cooke E, Deoni SC, D'Sa V, Rouse DJ, Carter EB, Tuuli MG. Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial. Am J Perinatol. 2022 Jun;39(8):808-815. doi: 10.1055/s-0041-1740003. Epub 2021 Nov 28.
- Results publication: PubMed 26971581Wong L, Smith S, Gilstrop M, Derman R, Auerbach S, London N, Lenowitz S, Bahrain H, McClintock J, Auerbach M. Safety and efficacy of rapid (1,000 mg in 1 hr) intravenous iron dextran for treatment of maternal iron deficient anemia of pregnancy. Am J Hematol. 2016 Jun;91(6):590-3. doi: 10.1002/ajh.24361. Epub 2016 Apr 13.
- Results publication: PubMed 36107229Hansen R, Sommer VM, Pinborg A, Krebs L, Thomsen LL, Moos T, Holm C. Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Arch Gynecol Obstet. 2023 Oct;308(4):1165-1173. doi: 10.1007/s00404-022-06768-x. Epub 2022 Sep 15.
- Results publication: PubMed 30121943Govindappagari S, Burwick RM. Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis. Am J Perinatol. 2019 Mar;36(4):366-376. doi: 10.1055/s-0038-1668555. Epub 2018 Aug 19.
- Results publication: PubMed 31413088Stoffel NU, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women. Haematologica. 2020 May;105(5):1232-1239. doi: 10.3324/haematol.2019.220830. Epub 2019 Aug 14.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Venofer 200 MG Per 10 ML Injection and Ferrous sulfate in people with Iron Deficiency Anemia of Pregnancy, run by Arrowhead Regional Medical Center at 1 site in United States.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin difference (time frame: Hemoglobin level obtained prior to treatment and then 4 weeks later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366698, which also lists 12 linked publications.
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 16 Apr 2024.