Parasitic Infection in Anemic Pregnant Women

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

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.

Study Overview

• Status: Unknown
• Conditions: Anemia of Pregnancy
• Intervention / Treatment: Drug: Iron Supplement; Drug: Metronidazole Oral; Drug: Albendazole

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Recruiting
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Metronidazole; Albendazole
• Other Study ID Numbers: 175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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