Doubling the Iron Dose to Prevent IDA in Twin Pregnant Women
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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 |
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.
Other Names:
|
| Experimental: 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 |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hemoglobin level below 11 g/dl [32 weeks gestation]
Iron deficiency anemia
- Hemoglobin level below 11 g/dl [24 hours before delivery]
incidence of Iron deficiency anemia
Secondary Outcome Measures
- blood product administration [24 hours after delivery]
Number of times of need for blood transfusion at delivery time
- GIT side effects [all over the pregnancy time 14 weeks gestation to delivery]
Incidence of Complications of iron supplementation mostly are GIT related
- Preterm Birth [delivery before 37 weeks gestation]
number of preterm birth
- neonatal Birth weidht [5 min. after delivery]
birth weight in Kg
Eligibility Criteria
Criteria
Inclusion Criteria:
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Twin pregnancy.
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Hemoglobin ≥ 10.5 gm/d l. at booking visit
Exclusion Criteria:
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Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation
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Thalassemia minor (alpha or beta).
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Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).
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Anemia from chronic illness.
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Any use of multi-vitamin supplements containing iron.
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Any chronic blood loss. e.g: hemorrhoids.
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Autoimmune disorders.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ahmed Abass | Cairo | Egypt | 11311 |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Study Chair: Khaled Ibrahem, Prof, AinShams U
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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