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OpenTrials
Completed

NCT Number: NCT03836703

Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Feroglobin single daily use

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.

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

Feroglobin twice daily dose

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.

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

Primary outcomes

  1. Hemoglobin level below 11 g/dl

    Time frame: 32 weeks gestation

    Iron deficiency anemia

  2. Hemoglobin level below 11 g/dl

    Time frame: 24 hours before delivery

    incidence of Iron deficiency anemia

Secondary outcomes

  1. blood product administration

    Time frame: 24 hours after delivery

    Number of times of need for blood transfusion at delivery time

  2. GIT side effects

    Time frame: all over the pregnancy time 14 weeks gestation to delivery

    Incidence of Complications of iron supplementation mostly are GIT related

  3. Preterm Birth

    Time frame: delivery before 37 weeks gestation

    number of preterm birth

  4. neonatal Birth weidht

    Time frame: 5 min. after delivery

    birth weight in Kg

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: IDA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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