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

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-237wbg
• Date of registration: 03/01/2013
• Primary sponsor: Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) - Brazil
• Public title: Usefulness of Complete Blood Count and Ferritin Measurement in the Anemia Diagnosis in Pregnancy
• Scientific title: Accuracy of Erythrocyte Indices and Serum Ferritin on Diagnosis of Iron-Deficiency Anemia in Pregnant Women: A Phase III Validation Study of Diagnostic Tests
• Date of first enrolment: 10/08/2011
• Target sample size: 278
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-237wbg/
• Study type: interventional
• Study design: Phase III validation study with before-after intervention

Countries of recruitment

Brazil

Contacts

• Name: Cristiane Bresani
• Affiliation: Instituto Nacional de Seguridade Social

• Name: Cristiane Bresani
• Affiliation: Instituto de Medicina Integral Prof Fernando Figueira

Key inclusion & exclusion 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: 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.

Age minimum: 18Y
Age maximum: 35Y
Gender: F

Health Condition(s) or Problem(s) studied

Anemia
C15.378.071.196.300
G08.686.785.760.769

Intervention(s)

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 ‘before-after’ intervention with daily oral iron and to define the final diagnosis of the functional iron deficiency.
The participants are women with a low-risk singleton pregnancy, between 18 and 35 years old, with gestational age between 12 and 32 weeks and Hb values greater than or equal to 7.0 g/dL and less than 11.0 g/dL. The recruitment procedure is a consecutive series of patients whose prenatal routine exams shown anemia (Hb < 11.0 g/dL). The target sample size is of 140 pregnant women. Considering rates of 30% of losses or poor adherence to treatment, 278 anemic pregnant women should be recruited. The prescribed treatment provides a follow-up period of 90 days. The follow-up is stopped before this period in case of evolution to high-risk pregnancy, genital bleeding, childbirth delivery, drop out of treatment, use of another type of iron supplement, drug intolerance, cure or aggravation of anemia. The participants ingest two daily doses of 109 mg of ferrous sulfate in the form of pills with 40 mg of elemental iron (Hematofer®, Prati Donaduzzi & Cia LTDA). Three blisters with 20 pills are given at the enrollment (C0) and at the two monthly revaluations (C1, C2). The pregnant women are oriented at each consultation to ingest the medication with a glass of drinking water, 30 minutes before a meal, and to preserve the non-consumed pills in the blisters. The evaluations occur monthly (C1, C2, C3), and information about gastrointestinal symptoms and therapeutic compliance is collected by a standardized form, such a venous blood sample to obtain Hb is prompted. Pregnant women who present drug intolerance, severe anemia (Hb < 7.0 g/dL) or Hb values drop more than 1.0 g/dL during the follow-up are referred to an individualized conduct. Those who present Hb > 11.0 g/dL befo

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

0240.0.099.095-10

2050-10

FR-379504

Source(s) of Monetary Support

Instituto de Medicina Integral Prof Fernando Figueira - Brazil

Secondary Sponsor(s)

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) - Brazil