Parasitic Infection in Anemic Pregnant Women
Primary Purpose
Anemia of Pregnancy
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Iron Supplement
Metronidazole Oral
Albendazole
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Pregnancy
Eligibility Criteria
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
Sites / Locations
- Kasr Alainy medical schoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Anemia without parasitic infection
parasitic infection treated with iron
parasitic infection treated with iron and antihelmemsic
Arm Description
women with anemia without parasitic infection will receive iron treatment
women with anemia with parasitic infection will receive oral iron treatment
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
Outcomes
Primary Outcome Measures
correction of naemia
hemoglobin level increased above 11 gm/dL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391998
Brief Title
Parasitic Infection in Anemic Pregnant Women
Official Title
Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anemia without parasitic infection
Arm Type
Active Comparator
Arm Description
women with anemia without parasitic infection will receive iron treatment
Arm Title
parasitic infection treated with iron
Arm Type
Active Comparator
Arm Description
women with anemia with parasitic infection will receive oral iron treatment
Arm Title
parasitic infection treated with iron and antihelmemsic
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Iron Supplement
Other Intervention Name(s)
Ferroglobin
Intervention Description
oral tablet twice daily after meals
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Other Intervention Name(s)
Flagyl
Intervention Description
500 mg oral twice daily
Intervention Type
Drug
Intervention Name(s)
Albendazole
Other Intervention Name(s)
alzental
Intervention Description
200 mg oral single dose
Primary Outcome Measure Information:
Title
correction of naemia
Description
hemoglobin level increased above 11 gm/dL
Time Frame
6 weeks after treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wesam deeb, MD
Phone
+201066302616
Email
wesameldeeb@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed maged, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Parasitic Infection in Anemic Pregnant Women
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