Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

Hematologic Pregnancy Complications Clinical Trial

— IDA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836703
• Other study ID #: 3201
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Pregnancy Complications
• Pregnancy Complications
• Pregnancy Complications, Hematologic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Abass	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level below 11 g/dl	Iron deficiency anemia	32 weeks gestation
Primary	Hemoglobin level below 11 g/dl	incidence of Iron deficiency anemia	24 hours before delivery
Secondary	blood product administration	Number of times of need for blood transfusion at delivery time	24 hours after delivery
Secondary	GIT side effects	Incidence of Complications of iron supplementation mostly are GIT related	all over the pregnancy time 14 weeks gestation to delivery
Secondary	Preterm Birth	number of preterm birth	delivery before 37 weeks gestation
Secondary	neonatal Birth weidht	birth weight in Kg	5 min. after delivery