Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Hematologic Pregnancy Complications

Treatments: Drug: Feroglobin twice daily dose; Drug: Feroglobin single daily use

Study type: Interventional

Funder types: Other

Identifiers

NCT03836703

3201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Single Dose Daily Iron

Active Comparator group

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

Treatment:

Drug: Feroglobin single daily use

Double dose Daily iron

Experimental group

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

Treatment:

Drug: Feroglobin twice daily dose