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Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia

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. Identifier: NCT03883841
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief 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. Maternal iron deficiency anemia is frequently associated with premature delivery, low birth weight babies

Condition or disease Intervention/treatment
Iron Deficiency Anemia Drug: Iron Sucrose Solution for Injection

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Fetal Vascular Hemodynamic Changes Before and After Treatment of Maternal Iron Deficiency Anemia
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Group/Cohort Intervention/treatment
Study group
patients with iron deficiency anemia
Drug: Iron Sucrose Solution for Injection
intravenous infusion of iron sucrose

control group
normal pregnant patients

Primary Outcome Measures :
  1. The mean changes in middle cerebral artery Doppler of the fetus [ Time Frame: one month ]
    Doppler evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study includes pregnant women 28 - 32 week gestation (calculated by the last menstrual period or by earlier ultrasound examination)

Inclusion Criteria:

  • Pregnant women with gestational age 28-32 weeks
  • singleton pregnancy
  • iron deficiency anemia.

Exclusion Criteria:

  • 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.

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University Identifier: NCT03883841    
Other Study ID Numbers: DIDA
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Ferric Oxide, Saccharated
Trace Elements
Growth Substances
Physiological Effects of Drugs