<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03836703</url>
  </required_header>
  <id_info>
    <org_study_id>3201</org_study_id>
    <nct_id>NCT03836703</nct_id>
  </id_info>
  <brief_title>Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women</brief_title>
  <acronym>IDA</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more&#xD;
      than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume&#xD;
      expansion as well as increased fetal and placental requirements.&#xD;
&#xD;
      With a lack of randomized controlled trials assessing the adequacy of iron supplements on&#xD;
      twin pregnancy, various recommendations are based on level 3 clinical expert opinions at&#xD;
      most.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18%&#xD;
      of all pregnant women during all three trimesters, with as many as 29%of women affected&#xD;
      during the third trimester.&#xD;
&#xD;
      In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more&#xD;
      than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume&#xD;
      expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin&#xD;
      (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations,&#xD;
      with a rate of IDA estimated to be 2.4 to even 4 times higher.&#xD;
&#xD;
      Expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies&#xD;
      recommends supplementation of iron beyond that contained in a typical prenatal vitamin.&#xD;
      Moreover, some experts support doubling the dose of multivitamins containing 30 mg of&#xD;
      elemental iron during the second and third trimesters of a twin pregnancy, regardless of&#xD;
      maternal Hgb and ferritin concentrations.&#xD;
&#xD;
      With a lack of randomized controlled trials assessing the adequacy of iron supplements on&#xD;
      twin pregnancy, various recommendations are based on level 3 clinical expert opinions at&#xD;
      most. The purpose of our study was to assess the efficacy of a single versus a double daily&#xD;
      iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of&#xD;
      this intervention on maternal iron stores and immediate neonatal outcome measures will assist&#xD;
      in defining evidence based recommendations for prenatal care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin level below 11 g/dl</measure>
    <time_frame>32 weeks gestation</time_frame>
    <description>Iron deficiency anemia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin level below 11 g/dl</measure>
    <time_frame>24 hours before delivery</time_frame>
    <description>incidence of Iron deficiency anemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood product administration</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>Number of times of need for blood transfusion at delivery time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GIT side effects</measure>
    <time_frame>all over the pregnancy time 14 weeks gestation to delivery</time_frame>
    <description>Incidence of Complications of iron supplementation mostly are GIT related</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm Birth</measure>
    <time_frame>delivery before 37 weeks gestation</time_frame>
    <description>number of preterm birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neonatal Birth weidht</measure>
    <time_frame>5 min. after delivery</time_frame>
    <description>birth weight in Kg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Hematologic Pregnancy Complications</condition>
  <arm_group>
    <arm_group_label>Single Dose Daily Iron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>single dose daily Iron'IRON FUM&amp;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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double dose Daily iron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double dose daily Iron'IRON FUM&amp;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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Feroglobin single daily use</intervention_name>
    <description>Feroglobin single daily use ( IRON FUM&amp;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.</description>
    <arm_group_label>Single Dose Daily Iron</arm_group_label>
    <other_name>IRON FUM&amp;POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Feroglobin twice daily dose</intervention_name>
    <description>Feroglobin twice daily dose ( IRON FUM&amp;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.</description>
    <arm_group_label>Double dose Daily iron</arm_group_label>
    <other_name>'IRON FUM&amp;POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Twin pregnancy.&#xD;
&#xD;
          -  Hemoglobin ≥ 10.5 gm/d l. at booking visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation&#xD;
&#xD;
          -  Thalassemia minor (alpha or beta).&#xD;
&#xD;
          -  Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease,&#xD;
             ulcerative colitis, previous bowel resection).&#xD;
&#xD;
          -  Anemia from chronic illness.&#xD;
&#xD;
          -  Any use of multi-vitamin supplements containing iron.&#xD;
&#xD;
          -  Any chronic blood loss. e.g: hemorrhoids.&#xD;
&#xD;
          -  Autoimmune disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khaled Ibrahem, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>AinShams U</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Abass</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>28829001</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25700159</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>January 16, 2021</last_update_submitted>
  <last_update_submitted_qc>January 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ahmed Abass</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Pregnancy, Twins , Iron Deficiency Anaemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Pregnancy Complications, Hematologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03836703
org study id: 3201
nct id: NCT03836703
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Hemoglobin level below 11 g/dl
time frame: 32 weeks gestation
description: Iron deficiency anemia
measure: Hemoglobin level below 11 g/dl
time frame: 24 hours before delivery
description: incidence of Iron deficiency anemia
measure: blood product administration
time frame: 24 hours after delivery
description: Number of times of need for blood transfusion at delivery time
measure: GIT side effects
time frame: all over the pregnancy time 14 weeks gestation to delivery
description: Incidence of Complications of iron supplementation mostly are GIT related
measure: Preterm Birth
time frame: delivery before 37 weeks gestation
description: number of preterm birth
measure: neonatal Birth weidht
time frame: 5 min. after delivery
description: birth weight in Kg
arm group label: Single Dose Daily Iron
arm group type: Active Comparator
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 group label: Double dose Daily iron
arm group type: Experimental
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: Feroglobin single daily use
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.
arm group label: Single Dose Daily Iron
other name: IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE
intervention type: Drug
intervention name: Feroglobin twice daily dose
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.
arm group label: Double dose Daily iron
other name: 'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khaled Ibrahem, Prof
role: Study Chair
affiliation: AinShams U
facility: 
country: Egypt
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.
PMID: 28829001
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.
PMID: 25700159
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ahmed Abass
investigator title: Lecturer
mesh term: Pregnancy Complications
mesh term: Pregnancy Complications, Hematologic
mesh term: Iron
sharing ipd: Undecided