Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia | NCT03883841

Studies
Fetal Vascular Hemodynamic Changes in Iron Deficiency Anemia

NCT03883841

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 21, 2019Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Iron Deficiency Anemia

Interventions

Iron Sucrose Solution for Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2019Estimated

Primary Completion Date

Aug 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Mar 19, 2019

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2019

Last Update Posted Date

Mar 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		patients with iron deficiency anemia	Drug: Iron Sucrose Solution for Injection
control group		normal pregnant patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron Sucrose Solution for Injection	Drug	intravenous infusion of iron sucrose	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007267	Injections

Ancestor Terms

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided