Pregnant women, less than 12 week of gestations,without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks
Conditions
Interventions
Trade Name: PROFER 40 mg Granulado
Product Name: PROFER 40 mg
Product Code: 830182
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: ferrimanitol ovalbumin
Other descriptive name: FER
Sponsors
Institut d?Investigació en Atenció Primaria IDIAP Jordi Gol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? adult woman ? ICS belonging to ? pregnant less than 12 weeks gestation ? to understand the Castilian or Catalan ? sign the informed consent ? without anemia (Hb =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Multiple or risk pregnancy. ? Taking iron supplements containing 10mg iron than in the previous three months ? Pregnant women with hypersensitivity to the active substance, hypersensitivity to egg proteins or intolerant to fructose or galactose. ? chronic or severe pre-existing disease that affects the nutritional development, such as cancer, diabetes mellitus and other metabolic diseases, malabsorptive diseases such as Crohn's disease, ulcerative colitis, gastro-duodenal ulcers, and liver diseases such as chronic hepatitis, liver cirrhosis and chronic pancreatitis. ? Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Decreasing the percentage of iron deficiency anemia at the end of gestation in women with baseline hemoglobin of 110 to 130 g / L, which is supplemented with 80 mg / day of iron regarding which are supplemented with 40 mg / day. ? Reduce the risk of hemoconcentration percentage at the end of pregnancy in women with baseline hemoglobin greater than 130 g / L, which are supplemented with 20 mg / day of iron compared to those who were supplemented with 40 mg / day.;Secondary Objective: ? Analyze the relationship that initial serum ferritin values ??and the presence of mutations in the HFE gene have on hemoglobin values??, the percentage of anemia and hemoconcentration risk at the end of gestation. ? Assess fetal anthropometric development, assessed by ultrasound, and the newborn in the groups supplemented with 80 or 20 mg / day of iron compared to the usual dose of 40 mg / day. ? Assess anthropometric development, cognitive and behavioral baby at 40 days of delivery, in the groups supplemented with 80 or 20 mg / day of iron compared to the usual dose of 40 mg / day. ? Assess the safety and adverse effects of treatment in the different branches of the test.;Primary end point(s): Haemoglobin Levels;Timepoint(s) of evaluation of this end point: week 36 of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assess the improved iron status and Hb by FS and assess the effect of the presence of polymorphisms C282Y, H63D HFE on iron status Assess anthropometric development of the fetus in the first ultrasound (nuchal translucideza through) in the second and third ultrasound (using the estimated weight of the fetus) and newborn (weight and height at birth) Assess development improved anthropometric (weight, length and head circumference) and neurorconductual development (using the Bayley Scales, Carey test and link test) infant Assess for adverse events in both arms throughout the whole trial;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Countries
Spain
Contacts
Public ContactPau Moreno
Institut d?Investigació en Atenció Primaria IDIAP Jordi Gol
Outcome results
None listed