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Determinants of Neonatal Anemia in Women Carrying Multiples
Study on Iron Levels in Pregnant Women with Twins or Triplets
Recruiting
19 years - 45 years
Female
Fase
1
2 Locations
Brief description of study
Multiple births in the United States are rapidly increasing in large part due to assisted reproductive technologies. Recent data indicate that multiple births now comprise 3-4.5% of all births in the United States. Pregnant women are at risk for iron (Fe) deficiency anemia yet there are virtually no data on Fe status in women carrying multiples and current recommendations do not necessitate Fe screening among this high risk group. Maternal anemia is known to increase the risk of adverse birth outcomes including preterm birth and low birth weight. Moreover, the developing brain is increasingly recognized to be susceptible to Fe insufficiency in utero and growing data support that suboptimal Fe stores at birth are associated with long-term irreversible cognitive deficits in the offspring. To address these gaps in knowledge the investigators will monitor weight gain, hematological measures, Fe status indicators and serum hepcidin across pregnancy in approximately 120 women carrying twins and triplets. Determinants of maternal anemia will be identified. Neonatal hematological measures will be assessed in cord blood from each neonate at birth for assessment of hematological measures, Fe status and hepcidin. Determinants of neonatal anemia will be identified. Inflammatory markers will be measured in all blood samples and related to outcomes. Stable iron isotopes will be given to a subset of women to assess maternal Fe absorption and fetal Fe uptake.
Detailed description of study
Pregnant women (n=100-125) carrying multiples (twins and triplets) will be identified when entering prenatal care. Women will be invited to participate in a longitudinal study of Fe homeostasis across pregnancy and at delivery in the maternal / neonatal dyad. In all maternal and cord blood samples obtained, whole blood will be analyzed for hemoglobin, hematocrit, reticulocyte count, erythrocyte count, mean corpuscular hemoglobin, mean corpuscular Hb concentration, mean corpuscular volume, and red cell distribution width using standard procedures. Circulating Fe status indicators (serum iron, ferritin, C-reactive protein, IL-6, erythropoietin, transferrin receptor and hepcidin) and serum folate and vitamin B12 will be measured. Distributions of each variable will be examined and associations among variables will be explored. Multiple linear regression models will be constructed to examine specific relations between a) determinants of Fe deficiency anemia in the mother; b) Fe status indicators in the mother vs. those in the neonate; c) Fe status indicators in the mother and neonate with placental Fe binding proteins; and d) neonatal Fe status between siblings.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Anaemia
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Age: 19 years - 45 years
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Gender: Female
Inclusion Criteria:
- The investigators anticipate that the majority of these women will be recruited early in gestation because many of these pregnancies are a result of assisted reproductive technology.
- Eligible volunteers will be otherwise healthy and have no diagnosed, preexisting medical conditions known to impact iron homeostasis
Exclusion Criteria:
- Hemoglobinopathies,
- Preexisting diabetes,
- Malabsorption diseases
Updated on
10 Jan 2025.
Study ID: NCT01582802
This study investigates iron levels in pregnant women who are expecting twins or triplets. Iron is important for making red blood cells, which carry oxygen in the body. Pregnant women need more iron, and not having enough can cause problems for both the mother and the babies.
The study will look at about 120 women who are pregnant with twins or triplets. Researchers will check their iron levels and other blood markers during pregnancy and at birth. They will also check the babies' iron levels at birth. Some women will get a special type of iron to see how well their bodies and their babies absorb it.
- Who can participate: Pregnant women expecting twins or triplets, who are otherwise healthy and do not have medical conditions affecting iron levels, can join the study
- Study details: The study will monitor iron levels and other blood markers in mothers and their babies. Some women will receive a special iron to study absorption, and stable iron isotopes will be used to assess maternal iron absorption and fetal iron uptake
