Iron Deficiency Anemia of PregnancyNCT05151679
Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy
A study testing Chelated Iron and Iron sucrose in people with Iron Deficiency Anemia of Pregnancy, run by Assiut University.
Trial summary
compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy. 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?
- Chelated Iron and Iron sucrose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Women aged 18 years or more with established iron deficiency anemia ( Hb: 8-10 )
- Pregnancy 26-34 weeks
Who cannot join
- Anemia due to other causes than iron deficiency anemia.
- Recent blood transfusion (in the last 3 months ).
- Allergy to iron.
- Multiple pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial )
compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy.
Read the detailed description
patients will be recruited from the pregnant women who will attend the outpatient clinic at Women's Health Hospital Assuit University with the diagnosis of iron deficiency anaemia between 26-34 weeks with Hb level 8-10 in the initial visit the patients will be counselled about the iron therapy, its benefits and risk of discontinuation written consent will be obtained.
All women will be subjected to the following:
- History taking
- Personal history: demographic factors, age and dietary habits.
- Obstetric history: parity, EDD, last delivery, gestational age determined from last menstrual period or previous early ultrasound scanning report.
- Past history: history of chronic diseases such as diabetes or hypertension, blood transfusion and either oral or i.v iron treatment.
- Clinical examination General examination including pulse, blood pressure, BMI, pallor, temperature and auscultation of lungs and heart. Abdominal examination for fundal level. The patients of the study will be randomly divided into two groups Group 1 will be treated by I.V ferrous sucrose Group 2 will be treated by chelated oral iron
- Invetigations
- Ultrasonography in the initial visit to assess fetal well being.
- Blood sample will be taken at recruitment on day 0, day 14, day 28, day 40 of therapy.these time points were chosen on the basis of previous studies and to minimize inconvenience to women. The time points were also chosen to detect any difference in the speed of restoration of Hb% and iron stores. The blood sample will be examined for the following:
- Complete blood picture. A sample of 2 ml venous blood will be collected in EDTA vacutainers.
- Serum ferritin evaluation. A sample of 2 ml venous blood will be collected in EDTA vacutainers and separated sera will be stored at 20 C until the time of assay by turbidimetric technique.
- Total iron binding capacity. A sample of 2 ml venous blood will be collected in EDTA vacutainers
- Doses and administration Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes, and then will be discontinued for another 30 minutes to detect any hypersensitivity reactions with monitoring of vital signs during infusion, antishock measures will be prepared beside the patient during administration ( corticosteroids, antihistaminic, calcium and oxygen ). Patients will be asked to note any symptoms or adverse effects of treatment such as facial flushing nausea, metallic taste, dyspepsia, and burning at the site of injection.
The dose in mg will be calculated from the following formula:
2.4 × weight × ( target - actual Hb ) I g/dl + 500 Target Hb 12 g% The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ). This group will not receive further iron supplementation. They will be asked to note any symptoms or adverse effects of treatment.
or to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment. Date will be given when to stop oral supplementation after 6 weeks. This group will be advised to note side effects such as nausea, metallic taste, dyspepsia and constipation.
We will add 500µg of folic acid to patients of group 1 once daily for 6 weeks to eliminate the differences in the results between the groups as ferrotron ( chelated oral iron for second group ) contains 400µg folic acid.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Chelated Iron, Iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chelated IronDrug
Also called ferrotron
Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes.
The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ).
Iron sucroseDrug
Also called sacrofer
to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia of PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Shaban Mohammed Farghaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151679
- Sponsor's protocol ID
- oral iron versus I.V iron
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
Publications
Bencaiova G, von Mandach U, Zimmermann R. Iron prophylaxis in pregnancy: intravenous route versus oral route. Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):135-9. doi: 10.1016/j.ejogrb.2009.03.006. Epub 2009 Apr 29.
PubMed 19406557Means RT. Iron Deficiency and Iron Deficiency Anemia: Implications and Impact in Pregnancy, Fetal Development, and Early Childhood Parameters. Nutrients. 2020 Feb 11;12(2):447. doi: 10.3390/nu12020447.
PubMed 32053933
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial )
- ClinicalTrials.gov ID
- NCT05151679
- Acronym / sponsor ID
- oral iron versus I.V iron
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- First posted
- 9 Dec 2021 (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.
compare the efficacy and safety of intravenous iron sucrose versus chelated oral iron in the treatment of iron deficiency anemia late in pregnancy.
Detailed description
patients will be recruited from the pregnant women who will attend the outpatient clinic at Women's Health Hospital Assuit University with the diagnosis of iron deficiency anaemia between 26-34 weeks with Hb level 8-10 in the initial visit the patients will be counselled about the iron therapy, its benefits and risk of discontinuation written consent will be obtained.
All women will be subjected to the following:
- History taking
- Personal history: demographic factors, age and dietary habits.
- Obstetric history: parity, EDD, last delivery, gestational age determined from last menstrual period or previous early ultrasound scanning report.
- Past history: history of chronic diseases such as diabetes or hypertension, blood transfusion and either oral or i.v iron treatment.
- Clinical examination General examination including pulse, blood pressure, BMI, pallor, temperature and auscultation of lungs and heart. Abdominal examination for fundal level. The patients of the study will be randomly divided into two groups Group 1 will be treated by I.V ferrous sucrose Group 2 will be treated by chelated oral iron
- Invetigations
- Ultrasonography in the initial visit to assess fetal well being.
- Blood sample will be taken at recruitment on day 0, day 14, day 28, day 40 of therapy.these time points were chosen on the basis of previous studies and to minimize inconvenience to women. The time points were also chosen to detect any difference in the speed of restoration of Hb% and iron stores. The blood sample will be examined for the following:
- Complete blood picture. A sample of 2 ml venous blood will be collected in EDTA vacutainers.
- Serum ferritin evaluation. A sample of 2 ml venous blood will be collected in EDTA vacutainers and separated sera will be stored at 20 C until the time of assay by turbidimetric technique.
- Total iron binding capacity. A sample of 2 ml venous blood will be collected in EDTA vacutainers
- Doses and administration Treatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes, and then will be discontinued for another 30 minutes to detect any hypersensitivity reactions with monitoring of vital signs during infusion, antishock measures will be prepared beside the patient during administration ( corticosteroids, antihistaminic, calcium and oxygen ). Patients will be asked to note any symptoms or adverse effects of treatment such as facial flushing nausea, metallic taste, dyspepsia, and burning at the site of injection.
The dose in mg will be calculated from the following formula:
2.4 × weight × ( target - actual Hb ) I g/dl + 500 Target Hb 12 g% The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ). This group will not receive further iron supplementation. They will be asked to note any symptoms or adverse effects of treatment.
or to group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment. Date will be given when to stop oral supplementation after 6 weeks. This group will be advised to note side effects such as nausea, metallic taste, dyspepsia and constipation.
We will add 500µg of folic acid to patients of group 1 once daily for 6 weeks to eliminate the differences in the results between the groups as ferrotron ( chelated oral iron for second group ) contains 400µg folic acid.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 years or more with established iron deficiency anemia ( Hb: 8-10 )
- Pregnancy 26-34 weeks
Key exclusion criteria (4 listed)
- Anemia due to other causes than iron deficiency anemia.
- Recent blood transfusion (in the last 3 months ).
- Allergy to iron.
- Multiple pregnancy.
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 |
|---|---|---|
| Chelated IronAlso: ferrotronTreatment will be started 24rh after initial visit women will be randomized used random sequence computer generated list in such a way that every patient had equal chance to be among any of the two groups either to group 1 , where they will receive I.V ferrous sucrose in the E.U in Women's Health Hospital Assuit University as an i.v infusion in 250 ml 0.9% sodium chloride slowly over 30 minutes. The total required dose of iron will be divided into three doses, which will be given every 3 days, and the maximum daily dose is 200mg ( 2 ampoules ). | Drug | – |
| Iron sucroseAlso: sacroferto group 2 where they will receive chelated oral iron, they will be given iron chelated amino acid containing 15 mg of elemental iron once daily for 6 weeks. the women will be advised to take 1 tab of iron chelated amino acid containing 15mg of elemental iron once daily with meals for 6 weeks from the day of recruitment. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Results publication: PubMed 19406557Bencaiova G, von Mandach U, Zimmermann R. Iron prophylaxis in pregnancy: intravenous route versus oral route. Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):135-9. doi: 10.1016/j.ejogrb.2009.03.006. Epub 2009 Apr 29.
- Results publication: PubMed 32053933Means RT. Iron Deficiency and Iron Deficiency Anemia: Implications and Impact in Pregnancy, Fetal Development, and Early Childhood Parameters. Nutrients. 2020 Feb 11;12(2):447. doi: 10.3390/nu12020447.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Chelated Iron and Iron sucrose in people with Iron Deficiency Anemia of Pregnancy, run by Assiut University.
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 2 inclusion and 4 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 9 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mahmoud farghaly, resident (+201005450572, mahmoudshaban8.ms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151679, which also lists 2 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 9 Dec 2021.