Iron Deficiency AnemiaNCT03883841
Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia
An observational study of Iron Deficiency Anemia, run by Assiut University.
Trial summary
Iron deficiency anemia is a worldwide medical disorder. So far, it is the most common medical complication in pregnancy specially in developing countries. It is the cause of many adverse effects on mother and fetus and contributes significantly to high maternal mortality. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Iron Sucrose Solution for Injection
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Oct 2020
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study includes pregnant women 28 - 32 week gestation (calculated by the last menstrual period or by earlier ultrasound examination)
Who may be able to join
- Pregnant women with gestational age 28-32 weeks
- singleton pregnancy
- iron deficiency anemia.
Who cannot join
- Multiple pregnancy
- antepartum hemorrhage
- major congenital fetal anomalies
- any other type of anemia other than iron deficiency anemia
- any acute or chronic maternal disease other than iron deficiency anemia.
About this study
Official title: Fetal Vascular Hemodynamic Changes Before and After Treatment of Maternal Iron Deficiency Anemia
Iron deficiency anemia is a worldwide medical disorder. So far, it is the most common medical complication in pregnancy specially in developing countries. It is the cause of many adverse effects on mother and fetus and contributes significantly to high maternal mortality. Maternal iron deficiency anemia is frequently associated with premature delivery, low birth weight babies
- Conditions
- Iron Deficiency Anemia
- Being tested
- Iron Sucrose Solution for Injection
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose Solution for InjectionDrug
intravenous infusion of iron sucrose
| Study group | Role | What they receive |
|---|---|---|
| Study group | patients with iron deficiency anemia Receives: Drug: Iron Sucrose Solution for Injection | |
| control group | normal pregnant patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean changes in middle cerebral artery Doppler of the fetus
Doppler evaluation
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883841
- Sponsor's protocol ID
- DIDA
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Vascular Hemodynamic Changes Before and After Treatment of Maternal Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT03883841
- Acronym / sponsor ID
- DIDA
- Conditions
- Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 21 Mar 2019 (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.
Iron deficiency anemia is a worldwide medical disorder. So far, it is the most common medical complication in pregnancy specially in developing countries. It is the cause of many adverse effects on mother and fetus and contributes significantly to high maternal mortality. Maternal iron deficiency anemia is frequently associated with premature delivery, low birth weight babies
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Iron Sucrose Solution for Injectionpatients with iron deficiency anemia |
| control group | – | –normal pregnant patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study includes pregnant women 28 - 32 week gestation (calculated by the last menstrual period or by earlier ultrasound examination)
Key inclusion criteria (3 listed)
- Pregnant women with gestational age 28-32 weeks
- singleton pregnancy
- iron deficiency anemia.
Key exclusion criteria (5 listed)
- Multiple pregnancy
- antepartum hemorrhage
- major congenital fetal anomalies
- any other type of anemia other than iron deficiency anemia
- any acute or chronic maternal disease other than iron deficiency anemia.
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 |
|---|---|---|
| Iron Sucrose Solution for Injectionintravenous infusion of iron sucrose | Drug | Study group |
Primary outcome
The mean changes in middle cerebral artery Doppler of the fetus
Time frame: one month
Doppler evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia, 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 3 inclusion and 5 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 21 Mar 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean changes in middle cerebral artery Doppler of the fetus (time frame: one month). 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 21 Mar 2019.