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Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women (IDA)

Primary Purpose

Hematologic Pregnancy Complications

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Feroglobin single daily use
Feroglobin twice daily dose
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematologic Pregnancy Complications focused on measuring Pregnancy, Twins , Iron Deficiency Anaemia

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Twin pregnancy.
  • Hemoglobin ≥ 10.5 gm/d l. at booking visit

Exclusion Criteria:

  • Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation
  • Thalassemia minor (alpha or beta).
  • Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).
  • Anemia from chronic illness.
  • Any use of multi-vitamin supplements containing iron.
  • Any chronic blood loss. e.g: hemorrhoids.
  • Autoimmune disorders.

Sites / Locations

  • Ahmed Abass

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single Dose Daily Iron

Double dose Daily iron

Arm Description

single dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia

Double dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia

Outcomes

Primary Outcome Measures

Hemoglobin level below 11 g/dl
Iron deficiency anemia
Hemoglobin level below 11 g/dl
incidence of Iron deficiency anemia

Secondary Outcome Measures

blood product administration
Number of times of need for blood transfusion at delivery time
GIT side effects
Incidence of Complications of iron supplementation mostly are GIT related
Preterm Birth
number of preterm birth
neonatal Birth weidht
birth weight in Kg

Full Information

First Posted
February 8, 2019
Last Updated
January 16, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03836703
Brief Title
Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women
Acronym
IDA
Official Title
Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

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
In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.
Detailed Description
Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester. In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of IDA estimated to be 2.4 to even 4 times higher. Expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. Moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal Hgb and ferritin concentrations. With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. The purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Pregnancy Complications
Keywords
Pregnancy, Twins , Iron Deficiency Anaemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Dose Daily Iron
Arm Type
Active Comparator
Arm Description
single dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia
Arm Title
Double dose Daily iron
Arm Type
Experimental
Arm Description
Double dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia
Intervention Type
Drug
Intervention Name(s)
Feroglobin single daily use
Other Intervention Name(s)
IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE
Intervention Description
Feroglobin single daily use ( IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.
Intervention Type
Drug
Intervention Name(s)
Feroglobin twice daily dose
Other Intervention Name(s)
'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE
Intervention Description
Feroglobin twice daily dose ( IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.
Primary Outcome Measure Information:
Title
Hemoglobin level below 11 g/dl
Description
Iron deficiency anemia
Time Frame
32 weeks gestation
Title
Hemoglobin level below 11 g/dl
Description
incidence of Iron deficiency anemia
Time Frame
24 hours before delivery
Secondary Outcome Measure Information:
Title
blood product administration
Description
Number of times of need for blood transfusion at delivery time
Time Frame
24 hours after delivery
Title
GIT side effects
Description
Incidence of Complications of iron supplementation mostly are GIT related
Time Frame
all over the pregnancy time 14 weeks gestation to delivery
Title
Preterm Birth
Description
number of preterm birth
Time Frame
delivery before 37 weeks gestation
Title
neonatal Birth weidht
Description
birth weight in Kg
Time Frame
5 min. after delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Twin pregnancy. Hemoglobin ≥ 10.5 gm/d l. at booking visit Exclusion Criteria: Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation Thalassemia minor (alpha or beta). Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection). Anemia from chronic illness. Any use of multi-vitamin supplements containing iron. Any chronic blood loss. e.g: hemorrhoids. Autoimmune disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Ibrahem, Prof
Organizational Affiliation
AinShams U
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Abass
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28829001
Citation
Shinar S, Skornick-Rapaport A, Maslovitz S. Iron Supplementation in Twin Pregnancy - The Benefit of Doubling the Iron Dose in Iron Deficient Pregnant Women: A Randomized Controlled Trial. Twin Res Hum Genet. 2017 Oct;20(5):419-424. doi: 10.1017/thg.2017.43. Epub 2017 Aug 22.
Results Reference
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PubMed Identifier
25700159
Citation
Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
Results Reference
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Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

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