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

Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Pregnancy Complications
• Intervention / Treatment: Drug: Feroglobin single daily use; Drug: Feroglobin twice daily dose

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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • Ahmed Abass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single Dose Daily Iron; 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	Drug: Feroglobin single daily use; 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.; Other Names: IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE
Experimental: Double dose Daily iron; 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	Drug: Feroglobin twice daily dose; 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.; Other Names: 'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin level below 11 g/dl	Iron deficiency anemia	32 weeks gestation
Hemoglobin level below 11 g/dl	incidence of Iron deficiency anemia	24 hours before delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood product administration	Number of times of need for blood transfusion at delivery time	24 hours after delivery
GIT side effects	Incidence of Complications of iron supplementation mostly are GIT related	all over the pregnancy time 14 weeks gestation to delivery
Preterm Birth	number of preterm birth	delivery before 37 weeks gestation
neonatal Birth weidht	birth weight in Kg	5 min. after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Khaled Ibrahem, Prof, Ainshams U

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy, Twins , Iron Deficiency Anaemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Pregnancy Complications; Pregnancy Complications, Hematologic; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 3201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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