Usefulness of Complete Blood Count and Ferritin Measurement in the Anemia Diagnosis in Pregnancy

Accuracy of Erythrocyte Indices and Serum Ferritin on Diagnosis of Iron-Deficiency Anemia in Pregnant Women: A Phase III Validation Study of Diagnostic Tests

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-237wbg

Enrollment

Unknown

Registered

2013-01-03

Start date

2011-08-10

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Anemia

Interventions

Open single-arm clinical trial without randomization or placebo control. Study with the purpose of observing the variation in the haemoglobin (Hb) values after a period of at least 4 weeks of a ‘befor

drug

SP4.011.097.144.184

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Hemoglobin concentration at least 0.7 and below 11.0 g/dL. Gestational age between 12 and 32 weeks of pregnancy. Low-risk pregnancy.

Exclusion criteria

Exclusion criteria: Hipersensibility or intolerability to ferros sulfate. Mental disease that precludes to understand the intervention. Unknowing the gestacional age. Another cause of anemia: sickel cell disease, talassemia, spherocytosis, autoimmune hemolytic anemia, leukemias, anemia of crônic disease. Sistemic infeccious diseases: human immunedeficiency virus, siphilis, urinary infeccion, leucocytosis. Tobacco, alcohol or other drugs use.

Design outcomes

Primary

Measure	Time frame
It is expected that the responsiveness to therapeutic test with oral iron (final diagnosis of functional iron deficiency) achieves an increase of at least 0.55 Z-score of haemoglobin after a minimum of 4 weeks treatment and an intake of at least 1200 mg of elemental iron (effective total dose). The primary outcome will be measured by the difference between the pre-treatment haemoglobin concentration (erythrogram collected on time-zero) and the post-treatment haemoglobin concentration (erythrogram collected on monthly revaluations 1, 2 or 3).	—

Measure

Time frame

It is expected that the responsiveness to therapeutic test with oral iron (final diagnosis of functional iron deficiency) achieves an increase of at least 0.55 Z-score of haemoglobin after a minimum of 4 weeks treatment and an intake of at least 1200 mg of elemental iron (effective total dose). The primary outcome will be measured by the difference between the pre-treatment haemoglobin concentration (erythrogram collected on time-zero) and the post-treatment haemoglobin concentration (erythrogram collected on monthly revaluations 1, 2 or 3).

—

Secondary

Measure	Time frame
It is expected that 70% of participants shown a 'good adherence' to the treatment that will be reported as an intake at least 75% of the prescribed monthly pills. This percentage was determined on the basis of the proportion of the monthly treatment prescribed that corresponds to the total monthly dose of 1800 mg of elemental iron, which is considered responsible for almost the entire effect in hemoglobin levels. The therapeutic adherence is being evaluated every 30 days according to pregnant women’s information and pill counting and recorded in the pregnant women´s individual form.;It is expected that at least 20% of participants complain about one or more of following adverse effects: abdominal pain/abdominal cramps, diarrhea (increasing number of evacuations or reduction of the stools consistency), constipation (reducing number of evacuations or hardening of stools), nausea, vomiting and heartburn (epygastric burning or epygastric pain). Their presence were defined as the appearance of the symptoms after the beginning of the intervention and are being evaluated every 30 days according to pregnant women´s information by a standardized questionnaire and recorded in the pregnant women´s individual form.	—

Measure

Time frame

It is expected that 70% of participants shown a 'good adherence' to the treatment that will be reported as an intake at least 75% of the prescribed monthly pills. This percentage was determined on the basis of the proportion of the monthly treatment prescribed that corresponds to the total monthly dose of 1800 mg of elemental iron, which is considered responsible for almost the entire effect in hemoglobin levels. The therapeutic adherence is being evaluated every 30 days according to pregnant women’s information and pill counting and recorded in the pregnant women´s individual form.;It is expected that at least 20% of participants complain about one or more of following adverse effects: abdominal pain/abdominal cramps, diarrhea (increasing number of evacuations or reduction of the stools consistency), constipation (reducing number of evacuations or hardening of stools), nausea, vomiting and heartburn (epygastric burning or epygastric pain). Their presence were defined as the appearance of the symptoms after the beginning of the intervention and are being evaluated every 30 days according to pregnant women´s information by a standardized questionnaire and recorded in the pregnant women´s individual form.

—

Countries

Brazil

Contacts

Public ContactCristiane Bresani

Instituto Nacional de Seguridade Social

Cristiane.bresani@inss.gov.br+55(81)9922-7164

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 12, 2026