Parasitic Infection in Anemic Pregnant Women

Anemia of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391998
• Other study ID #: 175
• Status: Recruiting
• Phase: Phase 4
• Start date: May 13, 2020
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: Ahmed maged, MD
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia of Pregnancy
• Parasitic Diseases

Intervention

Drug:
• Iron Supplement
oral tablet twice daily after meals
• Metronidazole Oral
500 mg oral twice daily
• Albendazole
200 mg oral single dose

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correction of naemia	hemoglobin level increased above 11 gm/dL	6 weeks after treatment