Anemia During Pregnancy
Conditions
Keywords
lactoferrin, iron deficiency anemia in pregnancy
Brief summary
130 pregnant women with Iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, packed-cell volume (PCV) , mean cell volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), Serum ferritin will be done at the start and the end of the treatment period.
Detailed description
The study will includes130 pregnant women, from the outpatient clinics in the Obstetrics and Gynecology Department, in Ain Shams University Hospital, Cairo, Egypt. Women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). Women will be enrolled and distributed into one of 2 groups by a computer generated random number table. Each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. One group named L will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named F will receive ferrous sulphate tablet and placebo in powder form. Hemoglobin concentration, PCV, MCV, MCH, MCHC, Serum ferritin will be done at the start and the end of the treatment period.
Interventions
DIETARY_SUPPLEMENTL (lactoferrin)
Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets
DRUGF (ferrous sulphate)
Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
Sponsors
Abdelwahed, Mai Mahmoud Mohamed, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant with singleton intrauterine pregnancy * 14- 20 weeks of gestation * Have iron deficiency anemia (IDA) with hemoglobin 9 to less than 10.5 g/dl.
Exclusion criteria
* Patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait). * Hemoglobin less than 9 g/dL. * Clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities. * History of acid-peptic disorders, esophagitis, or hiatal hernia. * Family history of thalassemia, sickle cell anemia, or malabsorption syndrome. * Medical disorders with pregnancy. * Bleeding in early pregnancy. * Allergies to milk proteins / hypersensitivity to iron preparations. * History of ingestion of any hematinics within the last 1 month before study entry. * Recent blood transfusion. * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Hemoglobin concentration | At time 0 (enrollment),1 and 2 months | grams/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean cell volume (MCV) | At time 0 (enrollment) and 2 months | fL/red cell in adult |
| mean corpuscular hemoglobin (MCH) | At time 0 (enrollment) and 2 months | picograms (pg)/cell in adults |
| mean cell hemoglobin concentration (MCHC) | At time 0 (enrollment) and 2 months | g/dL |
| Serum ferritin | At time 0 (enrollment) and 2 months | nanograms per milliliter |
| percentage of women who agree to take each of the two drugs for a future whole pregnancy. | At time 0 (enrollment) and every 2 weeks, for 2 months | percentage |
| Side effects: | At time 0 (enrollment) and every 2 weeks, for 2 months | scaling score of side effects of oral administration of bLf and ferrous sulfate as: * gastrointestinal discomfort * nausea * heart burn * constipation The degree of side effects will be assessed using objective scaling scoring system: 0 (no symptoms), 1 (mild not requiring any change in life style), 2 (severe controlled with another method), 3 (severe not controlled but accepting), 4 (severe not controlled and not accepting). |
| cost | 1-2 months | The average drug cost by LE. |
Countries
Egypt
Contacts
Primary ContactMai M Abdelwahed, specialist
Backup ContactGihan E El Hawwary, specialist
Outcome results
None listed