Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
| Registry | NCT04391998 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Anemia of Pregnancy |
| Interventions | Iron Supplement, Metronidazole Oral, Albendazole (Drug) |
| Dates | start 2020-05-13, primary completion 2021-08-01 (estimated), completion 2021-09-01 (estimated), first posted 2020-05-18, last updated 2021-02-09 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Anemia of Pregnancy All trials of Iron Supplement All trials of Metronidazole Oral
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Anemia without parasitic infection | Active comparator | Drug: Iron Supplement | women with anemia without parasitic infection will receive iron treatment |
| parasitic infection treated with iron | Active comparator | Drug: Iron Supplement | women with anemia with parasitic infection will receive oral iron treatment |
| parasitic infection treated with iron and antihelmemsic | Active comparator | Drug: Iron Supplement; Drug: Metronidazole Oral; Drug: Albendazole | 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 |
Sex: Female, ages: 18 Years to 45 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kasr Alainy medical school | Cairo | Egypt | Recruiting |