The Effectiveness of Different Doses of Iron Supplementation and the Prenatal Determinants of Maternal Iron Status in Pregnant Spanish Women: ECLIPSES Study

Abstract

Iron deficiency (ID), anemia, iron deficiency anemia (IDA) and excess iron (hemoconcentration) harm maternal–fetal health. We evaluated the effectiveness of different doses of iron supplementation adjusted for the initial levels of hemoglobin (Hb) on maternal iron status and described some associated prenatal determinants. The ECLIPSES study included 791 women, randomized into two groups: Stratum 1 (Hb = 110–130g/L, received 40 or 80mg iron daily) and Stratum 2 (Hb > 130g/L, received 20 or 40mg iron daily). Clinical, biochemical, and genetic information was collected during pregnancy, as were lifestyle and sociodemographic characteristics. In Stratum 1, using 80 mg/d instead of 40 mg/d protected against ID on week 36. Only women with ID on week 12 benefited from the protection against anemia and IDA by increasing Hb levels. In Stratum 2, using 20 mg/d instead of 40 mg/d reduced the risk of hemoconcentration in women with initial serum ferritin (SF) ≥ 15 μg/L, while 40 mg/d improved SF levels on week 36 in women with ID in early pregnancy. Mutations in the HFE gene increased the risk of hemoconcentration. Iron supplementation should be adjusted to early pregnancy levels of Hb and iron stores. Mutations of the HFE gene should be evaluated in women with high Hb levels in early pregnancy.

Nutrient Intake during Pregnancy and Post-Partum: ECLIPSES Study

“…High dosages of iron may also be harmful to child neurodevelopment [53]. In fact, a recent clinical trial in Spain conducted by our research team found that iron supplementation should be adapted individually to early pregnancy levels of hemoglobin and iron stores [55]. This study found high percentages of women, ranging from 7.39% to 11.9%, with iron deficiency anemia, and 6.8% to 13.1% of the pregnant women in our study were found to be at risk of hemoconcentration (hemoglobin >130 g/L [55].…”

High and Low Haemoglobin Levels in Early Pregnancy Are Associated to a Higher Risk of Miscarriage: A Population-Based Cohort Study

“…Furthermore, our findings show that raised Hb levels in early pregnancy can be as harmful as iron deficiency anaemia in terms of miscarriage and that the rate of high Hb levels during early pregnancy could be even more frequent than anaemia (6.2 vs. 3.8%). In this sense, this study suggests the need to revise the systematic advice of prophylactic iron supplementation, particularly in nonanemic pregnant women, in order to avoid the risk of high Hb level and defends a more personalised iron supplementation according to the iron status during antenatal check-ups [ 30 ].…”

Maternal Factors Associated with Levels of Fatty Acids, Specifically n-3 PUFA during Pregnancy: ECLIPSES Study

“…A prospective study of a cohort of pregnant women who were followed from the first trimester (T1) (around the 12th gestational week) to the third trimester (T3) (the 36th gestational week). The women were recruited from the ECLIPSES study [19,20], which is a randomized triple-blind clinical trial of different doses of iron supplementation (20 mg/day, 40 mg/day 80 mg/day), registered in ClinicalTrials.gov identification number NCT03196882, and in the European Union (EU) Clinical Trial Register, EUCTR-2012-005480-28. This study was approved by the Clinical Research Ethics Committee of the Jordi Gol Institute for Primary Care Research (IDIAP) and the Pere Virgili Institute for Health Research (IISPV).…”