Combifer vs Trofin phase II in anemic pregnant women.

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000192
• Date of registration: 08/04/2015
• Prospective Registration: Yes
• Primary sponsor: National Center of Bioproducts (BioCen)
• Public title: Combifer vs Trofin phase II in anemic pregnant women.
• Scientific title: Protocol Phase II Clinical Trial Combifer vs Trofin in the treatment of anemic pregnant women.
• Date of first enrolment: 30/04/2015
• Target sample size: 390
• Recruitment status: Suspended
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000192-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: Elisa Aznar García
• Affiliation: National Center of Bioproducts (BioCen)

• Name: Norma Silva Leal
• Affiliation: Teaching Hospital Maternal Children 10 de Octubre

Key inclusion & exclusion 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: 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 .


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

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

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 half hour before eating; for a duration of at most up to 8 months.

Primary Outcome(s)

Hemoglobin (Hb). Measurement time: at baseline, and every 8 weeks until childbirth.

Secondary Outcome(s)

- 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