NCT04391998

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

May 13, 2020

Last Update Submit

February 5, 2021

Conditions

Anemia of Pregnancy

Outcome Measures

Primary Outcomes (1)

  • correction of naemia

    hemoglobin level increased above 11 gm/dL

    6 weeks after treatment

Study Arms (3)

Anemia without parasitic infection

ACTIVE COMPARATOR

women with anemia without parasitic infection will receive iron treatment

Drug: Iron Supplement

parasitic infection treated with iron

ACTIVE COMPARATOR

women with anemia with parasitic infection will receive oral iron treatment

Drug: Iron Supplement

parasitic infection treated with iron and antihelmemsic

ACTIVE COMPARATOR

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 SupplementDrug: Metronidazole OralDrug: Albendazole

Interventions

Iron SupplementDRUG

oral tablet twice daily after meals

Also known as: Ferroglobin
Anemia without parasitic infectionparasitic infection treated with ironparasitic infection treated with iron and antihelmemsic
Metronidazole OralDRUG

500 mg oral twice daily

Also known as: Flagyl
parasitic infection treated with iron and antihelmemsic
AlbendazoleDRUG

200 mg oral single dose

Also known as: alzental
parasitic infection treated with iron and antihelmemsic

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Iron-Dextran ComplexMetronidazoleAlbendazole

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydratesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbamatesAcids, AcyclicCarboxylic AcidsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmed maged, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged, MD

CONTACT

+201005227404prof.ahmedmaged@gmail.com

Wesam deeb, MD

CONTACT

+201066302616wesameldeeb@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 18, 2020

Study Start

May 13, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

EG(1)