Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia

March 19, 2019 updated by: Ahmed Mohamed Abbas, Assiut University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean changes in middle cerebral artery Doppler of the fetus
Time Frame: one month
Doppler evaluation
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIDA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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