Parasitic Infection in Anemic Pregnant Women

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04391998
Collaborator
(none)
200
1
3
15.6
12.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
Actual Study Start Date :
May 13, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anemia without parasitic infection

women with anemia without parasitic infection will receive iron treatment

Drug: Iron Supplement
oral tablet twice daily after meals
Other Names:
  • Ferroglobin
  • Active Comparator: parasitic infection treated with iron

    women with anemia with parasitic infection will receive oral iron treatment

    Drug: Iron Supplement
    oral tablet twice daily after meals
    Other Names:
  • Ferroglobin
  • Active Comparator: parasitic infection treated with iron and antihelmemsic

    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
    oral tablet twice daily after meals
    Other Names:
  • Ferroglobin
  • Drug: Metronidazole Oral
    500 mg oral twice daily
    Other Names:
  • Flagyl
  • Drug: Albendazole
    200 mg oral single dose
    Other Names:
  • alzental
  • Outcome Measures

    Primary Outcome Measures

    1. correction of naemia [6 weeks after treatment]

      hemoglobin level increased above 11 gm/dL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed maged, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, PROFESSOR, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04391998
    Other Study ID Numbers:
    • 175
    First Posted:
    May 18, 2020
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 9, 2021