Anemia
Conditions
Interventions
Study Group I: Combifer 500 mg 3 tablets / day (orally) as follows: 1 tablet half hour before breakfast, another half hour before lunch and another half hour before eating
for a duration of at most up to 8 months.
Control Group II: Trofin 235 mL 3 tbsp (15 mL) / day (orally) as follows: 1 tablespoon half hour before breakfast, another half hour before lunch and another
for a duration of at most up to 8 months.
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
Female
Age
14 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have given their informed consent to participate in the trial. 2. Patients with pregnancy between 9 and 34 weeks. 3. Patients with hemoglobin levels between 70 and 109 g / L. 4. Patients who have not received transfusions two weeks before the study.
Exclusion criteria
Exclusion criteria: 1. Patients who present acute gastrointestinal disorders that mask treatment (vomiting, diarrhea). 2. Patients who received transfusions in the two prior weeks to their inclusion in the study .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin (Hb). Measurement time: at baseline, and every 8 weeks until childbirth. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Hematocrit (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Serum iron (mmol / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Reticulocytes (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Mean Corpuscular Volume (fl). Measurement time: at baseline, and every 8 weeks until childbirth. - Corpuscular Hemoglobin Media (pg). Measurement time: at baseline, and every 8 weeks until childbirth. - Mean Corpuscular Hemoglobin Concentration (g / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Distribution of erythrocytes Rate (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Middle Platelet Volume (fl). Measurement time: at baseline, and every 8 weeks until childbirth. - Platelet Distribution Rate (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Ferritin (ng / mL). Measurement time: at baseline, and every 8 weeks until childbirth. - Transferrin receptor (mg / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Adverse events (AE). Measurement time: at baseline, and every 8 weeks until childbirth. It will be measured by: Occurrence of some AE in the patient (yes/no). Description of the AE (Name of adverse event). According to available previous information (unexpected and expected). Intensity of the AE (Light, Moderate, Severe). Graveness of the AE (Serious, No serious). Attitude regarding the treatment in study without changes, temporary or definitive interruption of the treatment in study). Result of the AE (Recovered, Improved, Persists or sequels) Causal Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated) | — |
Countries
Cuba
Contacts
Public ContactNorma Silva Leal
Teaching Hospital Maternal Children 10 de Octubre
Outcome results
None listed