Fetal ConditionsNCT04016922
The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome
An observational study of Fetal Conditions, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Fetal Conditions
- What is being tested?
- Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2019to Oct 2019
- How long will I take part?
- 3 Months
- 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 20 to 35 years
- Women only
- Adult
Study population: * The pregnant women were divided into three groups: 1. Group A : Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl). 2. Group B : Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl). 3. Group C : Patients with severe anemia (Hb concentration: >7.0 g\dl).
Who may be able to join
- Pregnant females aged 20- 35 years.
- Gestational age 32 weeks or more.
- Living singleton fetus.
Who cannot join
- Multifetal pregnancy.
- Patients with chronic illness or medical disorders other than iron deficiency anemia.
- Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin deficiency anemia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasralainy hospital
Giza
Mai Elsayed, Assistant lecturer, 01153304548, maielsayed126@gmail.com
About this study
Official title: Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome
This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment.
Read the detailed description
Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl.
Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature.
IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%.
Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always > 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation).
Perinatal morbidity \& mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency.
Iron deficiency and iron deficiency anemia during pregnancy are risk factors for preterm delivery, prematurity and small for gestational age birth weight. Iron deficiency has a negative effect on intelligence and behavioral development in the infant. It is essential to prevent iron deficiency in the fetus by preventing iron deficiency in the pregnant woman.
Prevention and control is typically achieved through iron fortification of food staples like flour and rice and/or through administration of iron supplements most often in iron tablets. Although iron supplements are widely available and fortified foods constitute a major component of the diet in the developed world, access is limited in the developing world
- Conditions
- Fetal Conditions
- Being tested
- Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
- Keywords
- Fetal hemodynamics., Intrauterine growth restriction, Amniotic fluid index
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group COther
Also called routine medical care
Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio.
- Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
- As part of routine medical care of these patients, they are managed as:
A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon.
B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl). Receives: Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C | |
| Group B | Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl). Receives: Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C | |
| Group C | Patients with severe anemia (Hb concentration: >7.0 g\dl). Receives: Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fetal vascular doppler parameters.
Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.
Measured: 4 months from June 2019 till October 2019
Neonatal birth weight
Neonatal birth weight in kilograms
Measured: 4 months June 2019 till October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fetal ConditionsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Amin, Cairo University
- Investigators
- Muhamad Ehab, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016922
- Sponsor's protocol ID
- Fetal hemodynamics, neonates
- Status last verified
- Jul 2019
- First submitted
- 24 Jun 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.
PubMed 26404445Abu-Ouf NM, Jan MM. The impact of maternal iron deficiency and iron deficiency anemia on child's health. Saudi Med J. 2015 Feb;36(2):146-9. doi: 10.15537/smj.2015.2.10289.
PubMed 25719576Breymann C; Anaemia Working Group. [Current aspects of diagnosis and therapy of iron deficiency anemia in pregnancy]. Praxis (Bern 1994). 2001 Aug 2;90(31-32):1283-91. German.
PubMed 11519193Lee AI, Okam MM. Anemia in pregnancy. Hematol Oncol Clin North Am. 2011 Apr;25(2):241-59, vii. doi: 10.1016/j.hoc.2011.02.001.
PubMed 21444028Rasmussen K. Is There a Causal Relationship between Iron Deficiency or Iron-Deficiency Anemia and Weight at Birth, Length of Gestation and Perinatal Mortality? J Nutr. 2001 Feb;131(2S-2):590S-601S; discussion 601S-603S. doi: 10.1093/jn/131.2.590S.
PubMed 11160592
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome
- ClinicalTrials.gov ID
- NCT04016922
- Acronym / sponsor ID
- Fetal hemodynamics, neonates
- Conditions
- Fetal Conditions
- Keywords
- Fetal hemodynamics., Intrauterine growth restriction, Amniotic fluid index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Jul 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.
This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment.
Detailed description
Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl.
Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature.
IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%.
Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always > 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation).
Perinatal morbidity \& mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency.
Iron deficiency and iron deficiency anemia during pregnancy are risk factors for preterm delivery, prematurity and small for gestational age birth weight. Iron deficiency has a negative effect on intelligence and behavioral development in the infant. It is essential to prevent iron deficiency in the fetus by preventing iron deficiency in the pregnant woman.
Prevention and control is typically achieved through iron fortification of food staples like flour and rice and/or through administration of iron supplements most often in iron tablets. Although iron supplements are widely available and fortified foods constitute a major component of the diet in the developed world, access is limited in the developing world
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group CPatients with mild anemia (Hb concentration: 9.0-10.9 g\dl). |
| Group B | – | Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group CPatients with moderate anemia (Hb concentration: 7.0-8.9 g\dl). |
| Group C | – | Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group CPatients with severe anemia (Hb concentration: >7.0 g\dl). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- * The pregnant women were divided into three groups: 1. Group A : Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl). 2. Group B : Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl). 3. Group C : Patients with severe anemia (Hb concentration: >7.0 g\dl).
Key inclusion criteria (3 listed)
- Pregnant females aged 20- 35 years.
- Gestational age 32 weeks or more.
- Living singleton fetus.
Key exclusion criteria (3 listed)
- Multifetal pregnancy.
- Patients with chronic illness or medical disorders other than iron deficiency anemia.
- Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin 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 |
|---|---|---|
| Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group CAlso: routine medical careConsent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio. * Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD . * As part of routine medical care of these patients, they are managed as: A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US. | Other | Group A, Group B, Group C |
Primary outcome
Changes in fetal vascular doppler parameters.
Time frame: 4 months from June 2019 till October 2019
Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.
Neonatal birth weight
Time frame: 4 months June 2019 till October 2019
Neonatal birth weight in kilograms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 26404445Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.
- Background: PubMed 25719576Abu-Ouf NM, Jan MM. The impact of maternal iron deficiency and iron deficiency anemia on child's health. Saudi Med J. 2015 Feb;36(2):146-9. doi: 10.15537/smj.2015.2.10289.
- Background: PubMed 11519193Breymann C; Anaemia Working Group. [Current aspects of diagnosis and therapy of iron deficiency anemia in pregnancy]. Praxis (Bern 1994). 2001 Aug 2;90(31-32):1283-91. German.
- Background: PubMed 21444028Lee AI, Okam MM. Anemia in pregnancy. Hematol Oncol Clin North Am. 2011 Apr;25(2):241-59, vii. doi: 10.1016/j.hoc.2011.02.001.
- Background: PubMed 11160592Rasmussen K. Is There a Causal Relationship between Iron Deficiency or Iron-Deficiency Anemia and Weight at Birth, Length of Gestation and Perinatal Mortality? J Nutr. 2001 Feb;131(2S-2):590S-601S; discussion 601S-603S. doi: 10.1093/jn/131.2.590S.
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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.
Muhamad Ehab, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Conditions, run by Cairo University at 1 site in Egypt.
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 3 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 Jul 2019. 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 Egypt. 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. 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 Mai Assistant lecturer (01153304548, maielsayed126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fetal vascular doppler parameters. (time frame: 4 months from June 2019 till October 2019). The study lists 2 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 NCT04016922, which also lists 5 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 Jul 2019.