NCT04149548

Brief Summary

Diabetes mellitus is one of the major heath problems

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

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

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

October 31, 2019

Last Update Submit

February 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of diabetic fetuses who will have undesirable effects

    Number of fetuses with macrosomia and other diabetes effects

    within 6 months

Study Arms (2)

pregnant diabetic women

Fetal Ultrasound to diabetic pregnant women

Diagnostic Test: ultrasound

non diabetic pregnant women

Fetal ultrasound to non diabetic pregnant women

Diagnostic Test: ultrasound

Interventions

ultrasoundDIAGNOSTIC_TEST

Obstetric ultrasound to pregnant women

non diabetic pregnant womenpregnant diabetic women

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diabetic and non diabetic pregnanrt women attending for ANC

You may qualify if:

  • in control group A non diabetic pregnant women

You may not qualify if:

  • Diabetic pregnant women
  • And the reverse in group B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Algazeerah and Kasralainy hospital

Giza, Egypt

RECRUITING

Algazeerah

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher ,National research centre and Algezeera hospital

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

November 5, 2019

Primary Completion

November 6, 2020

Study Completion

December 1, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations