The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome
NCT ID: NCT04016922
Last Updated: 2019-07-16
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2019-07-31
2019-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
Patients with mild anemia (Hb concentration: 9.0-10.9 g\\dl).
Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
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.
Group B
Patients with moderate anemia (Hb concentration: 7.0-8.9 g\\dl).
Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
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.
Group C
Patients with severe anemia (Hb concentration: \>7.0 g\\dl).
Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
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.
Interventions
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Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age 32 weeks or more.
* Living singleton fetus.
Exclusion Criteria
* 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.
20 Years
35 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mai Elsayed Amin
Assistant lecturer
Principal Investigators
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Muhamad Ehab, professor
Role: STUDY_CHAIR
Cairo University
Locations
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Kasralainy hospital
Giza, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Abu-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.
Breymann 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.
Lee 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.
Rasmussen 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.
Other Identifiers
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Fetal hemodynamics, neonates
Identifier Type: -
Identifier Source: org_study_id
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