Combifer vs NeotrofinCF-Anemia-Pregnant-Phase II

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000193
• Date of registration: 13/04/2015
• Prospective Registration: Yes
• Primary sponsor: National Center of Bioproducts (BioCen)
• Public title: Combifer vs NeotrofinCF-Anemia-Pregnant-Phase II
• Scientific title: Phase II Clinical Study of antianemics Neotrofin CF vs Combifer in pregnant women with anemia
• Date of first enrolment: //None
• Target sample size: 390
• Recruitment status: Suspended
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000193-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Norma Silva Leal
• Affiliation: Teaching Hospital Maternal Child October 10

• Name: Elisa María Aznar García
• Affiliation: National Center of Bioproducts (BioCen)

Key inclusion & exclusion 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: 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..


Age minimum: 14 years
Age maximum: 45 years
Gender: Female

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

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 dinner orally) for no more than 8 months.

Primary Outcome(s)

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

Secondary Outcome(s)

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)

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

National Center of Bioproducts (BioCen) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable