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Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial (FAIR)

Primary Purpose

Iron Deficiency (Without Anemia), Pregnancy Related

Status
Unknown status
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Parentral Iron
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency (Without Anemia) focused on measuring anemia, ferritin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-anaemic iron deficiency

Exclusion Criteria:

  • Anaemia or normal iron stores

Sites / Locations

  • TAYYIBA WasimRecruiting
  • Allama Iqbal Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Prophylaxis

Arm Description

Intravenous Iron to correct Iron deficiency without anaemia

Usual antenatal care

Outcomes

Primary Outcome Measures

Maternal anaemia
Haemoglobin concentration (g/dl)

Secondary Outcome Measures

Fetal growth restriction
Birthweight for gestational age (percentile)

Full Information

First Posted
January 9, 2020
Last Updated
January 11, 2020
Sponsor
Services Institute of Medical Sciences, Pakistan
Collaborators
Allama Iqbal Medical College, Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04228627
Brief Title
Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial
Acronym
FAIR
Official Title
Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention - a Multi Centre Randomised Controlled Trial (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan
Collaborators
Allama Iqbal Medical College, Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.
Detailed Description
Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency (Without Anemia), Pregnancy Related
Keywords
anemia, ferritin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Multi centre randomised trial
Masking
Investigator
Masking Description
Allocation concealment
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Intravenous Iron to correct Iron deficiency without anaemia
Arm Title
Prophylaxis
Arm Type
No Intervention
Arm Description
Usual antenatal care
Intervention Type
Drug
Intervention Name(s)
Parentral Iron
Intervention Description
Correction of Iron stores without anaemia
Primary Outcome Measure Information:
Title
Maternal anaemia
Description
Haemoglobin concentration (g/dl)
Time Frame
36 weeks' gestation
Secondary Outcome Measure Information:
Title
Fetal growth restriction
Description
Birthweight for gestational age (percentile)
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-anaemic iron deficiency Exclusion Criteria: Anaemia or normal iron stores
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TAYYIBA Wasim
Phone
03008400197
Email
tayyibawasim@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAYYIBA Wasim
Organizational Affiliation
Services Institute of Medical Sciences, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
TAYYIBA Wasim
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54590
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAYYIBA Wasim
Phone
03008400197
Email
tayyibawasim@yahoo.com
Facility Name
Allama Iqbal Medical College
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
On completion of study we will happily discuss data sharing with any legitimate party with an IPD meta-analysis protocol.
IPD Sharing Time Frame
Following publication of study
IPD Sharing Access Criteria
An acceptable IPD meta-analysis protocol with a suitable data sharing agreement
Citations:
PubMed Identifier
26256281
Citation
Pratt JJ, Khan KS. Non-anaemic iron deficiency - a disease looking for recognition of diagnosis: a systematic review. Eur J Haematol. 2016 Jun;96(6):618-28. doi: 10.1111/ejh.12645. Epub 2015 Sep 17.
Results Reference
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Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial

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