Parasitic Infection in Anemic Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anemia without parasitic infection

women with anemia without parasitic infection will receive iron treatment

Group Type ACTIVE_COMPARATOR

Iron Supplement

Intervention Type DRUG

oral tablet twice daily after meals

parasitic infection treated with iron

women with anemia with parasitic infection will receive oral iron treatment

Group Type ACTIVE_COMPARATOR

Iron Supplement

Intervention Type DRUG

oral tablet twice daily after meals

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

Group Type ACTIVE_COMPARATOR

Iron Supplement

Intervention Type DRUG

oral tablet twice daily after meals

Metronidazole Oral

Intervention Type DRUG

500 mg oral twice daily

Albendazole

Intervention Type DRUG

200 mg oral single dose

Interventions

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Iron Supplement

oral tablet twice daily after meals

Intervention Type DRUG

Metronidazole Oral

500 mg oral twice daily

Intervention Type DRUG

Albendazole

200 mg oral single dose

Intervention Type DRUG

Other Intervention Names

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Ferroglobin Flagyl alzental

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No