NCT03755024

Brief Summary

Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 25, 2018

Last Update Submit

November 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts

    correlation of fetal growth pattern with neonatal birth weight and outcome

    8 months

Study Arms (2)

normal group

fetuses with normal growth

Device: ultrasound

Growth retardation group

fetuses with retarded growth

Device: ultrasound

Interventions

The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters: * Biparietal diameter * Head circumference * Abdominal circumference * Femur length * Humerus length

Growth retardation groupnormal group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.

You may qualify if:

  • They have body-mass index between 18-30;
  • They have a singleton pregnancy;
  • Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual period.

You may not qualify if:

  • Multiple pregnancy
  • Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 27, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

May 1, 2020

Last Updated

November 27, 2018

Record last verified: 2018-11