Parasitic Infection in Anemic Pregnant Women

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Anemia of Pregnancy

Treatments: Drug: Albendazole; Drug: Iron Supplement; Drug: Metronidazole Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT04391998

175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Anemia without parasitic infection

Active Comparator group

Description:

women with anemia without parasitic infection will receive iron treatment

Treatment:

Drug: Iron Supplement

parasitic infection treated with iron

Active Comparator group

Description:

women with anemia with parasitic infection will receive oral iron treatment

Treatment:

Drug: Iron Supplement

parasitic infection treated with iron and antihelmemsic

Active Comparator group

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

Treatment:

Drug: Metronidazole Oral

Drug: Iron Supplement

Drug: Albendazole