Combifer vs NeotrofinCF-Anemia-Pregnant-Phase II

Phase II Clinical Study of antianemics Neotrofin CF vs Combifer in pregnant women with anemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000193

Enrollment

390

Registered

2015-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Interventions

Group I (Experimental): Neotrofin CF 3 tablets (400mg) a day (breakfast, lunch and dinner orally) for no more than 8 months. Group II (Control): Combifer 3 tablets (300mg) a day (breakfast, lunch and

Eligibility

Sex/Gender

Female

Age

14 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patients with pregnancy between 9 and 34 weeks of gestation. 2. Patients with figures hemoglobin less than 110 g / L. 3. Patients who have not received transfusions two weeks before the study. 4. Patients who do not have acute gastrointestinal disorders that mask treatment. 5. Patients who do not have severe anemia (hemoglobin less than 70 g / L). 6. Patients who gave their informed consent participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with diseases that cause diarrhea and vomiting. 2. Patients who received transfusions or specific treatment with iron during the two months prior to the study..

Design outcomes

Primary

Measure	Time frame
-Hemoglogin (g/L). Measurement time: at baseline, and every 8 weeks until childbirth.	—

Secondary

Measure	Time frame
Hematologic - 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)	—

Measure

Time frame

Hematologic - 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)

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Countries

Cuba

Contacts

Public ContactNorma Silva Leal

Teaching Hospital Maternal Child October 10

hijasgal@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026