Parasitic Infection in Anemic Pregnant Women

Study Overview
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Brief Summary
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Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.

Detailed Description
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All patients in the study were subjected to: Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded. General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant. Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration. Diagnosis of parasitic infection by stool analysis using suitable techniques. Imaging including obstetric ultrasound (U/S) to assess fetal development. Women with helminthic infections will be divided into groups Group (A): received iron + antiparasitic treatment as follows: Patients who have STH received alzental 200mg tab 2 tabs single oral dose. Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days. (B): received iron only.

Official Title
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Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.

Conditions
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Anemia of Pregnancy

Intervention / Treatment
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* Drug: Iron Supplement
* Drug: Metronidazole Oral
* Drug: Albendazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) hemoglobin level below 10.5 mg /dL Exclusion Criteria: women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis. Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anemia without parasitic infection<br>women with anemia without parasitic infection will receive iron treatment | Drug: Iron Supplement<br>* oral tablet twice daily after meals<br>* Other names: Ferroglobin;|
| Active Comparator: parasitic infection treated with iron<br>women with anemia with parasitic infection will receive oral iron treatment | Drug: Iron Supplement<br>* oral tablet twice daily after meals<br>* Other names: Ferroglobin;|
| Active Comparator: parasitic infection treated with iron and antihelmemsic<br>women with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab | Drug: Iron Supplement<br>* oral tablet twice daily after meals<br>* Other names: Ferroglobin;Drug: Metronidazole Oral<br>* 500 mg oral twice daily<br>* Other names: Flagyl;Drug: Albendazole<br>* 200 mg oral single dose<br>* Other names: alzental;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correction of naemia | hemoglobin level increased above 11 gm/dL | 6 weeks after treatment |