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The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016922
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mai Elsayed Amin, Cairo University

Brief 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.

Condition or disease Intervention/treatment
Fetal Conditions Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Group/Cohort Intervention/treatment
Group A
Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl).
Other: 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 Name: routine medical care

Group B
Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl).
Other: 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 Name: routine medical care

Group C
Patients with severe anemia (Hb concentration: >7.0 g\dl).
Other: 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 Name: routine medical care




Primary Outcome Measures :
  1. 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.

  2. Neonatal birth weight [ Time Frame: 4 months June 2019 till October 2019 ]
    Neonatal birth weight in kilograms



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • Pregnant females aged 20- 35 years.
  • Gestational age 32 weeks or more.
  • Living singleton fetus.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016922


Contacts
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Contact: Mai Assistant lecturer 01153304548 maielsayed126@gmail.com
Contact: Ahmad Hamdi, lecturer 01001980841 A.hamdi15@yahoo.com

Locations
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Egypt
Kasralainy hospital
Giza, Egypt
Contact: Mai Elsayed, Assistant lecturer    01153304548    maielsayed126@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Muhamad Ehab, professor Cairo University
Publications:
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Responsible Party: Mai Elsayed Amin, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04016922    
Other Study ID Numbers: Fetal hemodynamics, neonates
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mai Elsayed Amin, Cairo University:
Fetal hemodynamics.
Intrauterine growth restriction
Amniotic fluid index
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Oxide, Saccharated
Hematinics