O990 Anaemia complicating pregnancy, childbirth and the puerperium Anaemia complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
The Participant will receive one FERANIN FOL 1000 ® pill + Two Ferrous Sulfate Placebo pills orally once a day for a maximum of 90 days. -
The Participant will receive two table
Sponsors
QUIMICA SUIZA SOCIEDAD ANONIMA CERRADA - QUIMICA SUIZA S.A.C.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant participants in the 1st trimester of pregnancy (start of gestation through 12 weeks) who are 18 years of age or older. 2. With a diagnosis of iron deficiency anemia (Hb concentration <11g/dl and serum ferritin concentration <20 µg/L). 3. Be able to understand, sign and date an informed consent document according to the guidelines of good clinical practice and local regulations. 4. Consent signed and dated by the father of the conceived except death, irrefutable impossibility, loss of rights in accordance with current regulations. 5. Commitment to comply with assigned treatment and tests. 6. Desire to adhere to the treatment and follow-up program.
Exclusion criteria
Exclusion criteria: 1. Participantes embarazadas en el 2do y/o 3er trimestre mayores y/o menores de 18 años que tengan o esten recibiendo prescripcion medica para tratamiento de Deficiencia de Hierro durante el embarazo. 2. Sobrecarga de hierro en el cuerpo (hemocromatosis, hemolisis cronica). 3. Alteraciones en el uso del hierro (anemia por plomo, anemia sideroacretica), Talasemia. 4. Anemia megaloblastica, por insuficiencia de vitamina B12. 5. En casos de anemia infecciosa. 6. Antecedentes de anemia relacionada con enfermedades cronicas (cancer o alguna otra enfermedad cronica). 7. Antecedentes de anemia por hemorragia gastrointestinal, enfermedades autoinmunes, hepaticas o renales. 8. Hipersensibilidad al polimaltosato de hierro. 9. Anemia no ferropenica. 10. Hipersensibilidad al acido folico.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood test NAME OF THE RESULT: Change in Hemoglobin values (g/dL) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Evaluation from the beginning (day 0) until days 60 and 90 after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| AE report in the FRCe. NAME OF THE RESULT: Frequency of adverse events. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From day 1 to day 97. ;Blood test NAME OF THE RESULT: Change in Hemoglobin values (g/dL) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Evaluation from the beginning (day 0) until days 60 and 90 after starting treatment. ;Blood test. NAME OF THE RESULT: Change in Hb value (g/dL) in the first month. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Evaluation from baseline (day 0) to day 30 after starting treatment. ;Blood test. NAME OF THE RESULT: Change in serum ferritin value (ug/ml) at the end of treatment. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Evaluation from the beginning (day 0) until days 60 and 90 after starting treatment. ;Blood test. NAME OF THE RESULT: Change in values of hematocrit (%), mean corpuscular volume (fL), mean corpuscular hemoglobin (HbCM, pg), and mean corpuscular hemoglobin concentration (MCHC, g/dL). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Evaluation from the beginning (day 0) until days 60 and 90 after starting treatment. | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
QUIMICA SUIZA SOCIEDAD ANONIMA CERRADA - QUIMICA SUIZA S.A.C.
Outcome results
None listed