Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

Phase 4

Completed

• Conditions: Hematologic Pregnancy Complications
• Interventions: Drug: Feroglobin single daily use; Drug: Feroglobin twice daily dose

• Registration Number: NCT03836703
• Lead Sponsor: Ain Shams University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Primary Completion: 2020-07-01
• Study Completion: 2020-08-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose Daily Iron	Feroglobin single daily use	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	Feroglobin twice daily dose	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

Primary Outcome Measures

Name	Time	Method
Hemoglobin level below 11 g/dl	24 hours before delivery	incidence of Iron deficiency anemia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ahmed Abass; 🇪🇬 Cairo, Egypt