Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

NCT ID: NCT03836703

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-08-01

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.

Conditions

Hematologic Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Feroglobin single daily use

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Feroglobin twice daily dose

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE; 'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abass

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled Ibrahem, Prof

Role: STUDY_CHAIR

AinShams U

Locations

Ahmed Abass

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 28829001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25700159 (View on PubMed)

Other Identifiers

3201

Identifier Type: -

Identifier Source: org_study_id