Determinants of Neonatal Anemia in Women Carrying Multiples
Palabras clave
Abstracto
Descripción
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.
fechas
Verificado por última vez: | 01/31/2020 |
Primero enviado: | 04/11/2012 |
Inscripción estimada enviada: | 04/18/2012 |
Publicado por primera vez: | 04/22/2012 |
Última actualización enviada: | 02/05/2020 |
Última actualización publicada: | 02/06/2020 |
Fecha de inicio real del estudio: | 06/30/2011 |
Fecha estimada de finalización primaria: | 11/30/2017 |
Fecha estimada de finalización del estudio: | 11/30/2020 |
Condición o enfermedad
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Pregnant women carrying multiples |
Criterio de elegibilidad
Edades elegibles para estudiar | 19 Years A 19 Years |
Sexos elegibles para estudiar | Female |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
1. Maternal iron status [Biochemical measures will be obtained whenever women have blood drawn across pregnancy (there are no fixed time points for sampling). These will be obtained over an approximate 36 week interval]
2. Neonatal iron status at birth [Umbilical cord blood will be collected at birth]
3. Determinants of inter- and intra-uterine variance of neonatal iron status [Umbilical cord blood will be collected at birth]
Medidas de resultado secundarias
1. Effect of maternal Fe status on placental iron transporter expression [Participants will be followed over the course of gestation from approximately week 12 of pregnancy until term]
2. Maternal iron absorption and Fe57 enrichment in cord blood [Participants will be given 10 mg of stable iron between week 27-32 of gestation. Blood will be drawn 2 weeks post-dosing and maternal and umbilical cord blood will be obtained at delivery]