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Parasitic Infection in Anemic Pregnant Women

Phase 4
Conditions
Anemia of Pregnancy
Interventions
Registration Number
NCT04391998
Lead Sponsor
Cairo University
Brief Summary

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

All patients in the study were subjected to:

1. 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.

2. General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.

3. Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.

4. Diagnosis of parasitic infection by stool analysis using suitable techniques.

5. Imaging including obstetric ultrasound (U/S) to assess fetal development.

6. 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anemia without parasitic infectionIron Supplementwomen with anemia without parasitic infection will receive iron treatment
parasitic infection treated with ironIron Supplementwomen with anemia with parasitic infection will receive oral iron treatment
parasitic infection treated with iron and antihelmemsicMetronidazole Oralwomen 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
parasitic infection treated with iron and antihelmemsicIron Supplementwomen 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
parasitic infection treated with iron and antihelmemsicAlbendazolewomen 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
Primary Outcome Measures
NameTimeMethod
correction of naemia6 weeks after treatment

hemoglobin level increased above 11 gm/dL

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kasr Alainy medical school

🇪🇬

Cairo, Egypt

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