NCT03883841

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

March 19, 2019

Last Update Submit

March 19, 2019

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • The mean changes in middle cerebral artery Doppler of the fetus

    Doppler evaluation

    one month

Study Arms (2)

Study group

patients with iron deficiency anemia

Drug: Iron Sucrose Solution for Injection

control group

normal pregnant patients

Interventions

Iron Sucrose Solution for InjectionDRUG

intravenous infusion of iron sucrose

Study group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study includes pregnant women 28 - 32 week gestation (calculated by the last menstrual period or by earlier ultrasound examination)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Injections

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

May 1, 2019

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

March 21, 2019

Record last verified: 2019-03