NCT01178619

Brief Summary

Intrauterine growth restriction is being suspected in cases where the fetal estimated weight is less then the 10 th percentile for its gestational age. Abdominal circumference is the most influenced measurement in this cases. Head circumference on the other hand can be or not be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this observational study we will include pregnant women between 28-37 gestational week with a singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and the CC, abdominal circumference, head circumference and femur length. we will compeer these measurements according to the following groups:normal fetuses, symmetrical and asymmetrical IUGR.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Status
withdrawn

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

August 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

August 8, 2010

Last Update Submit

August 27, 2013

Conditions

Keywords

IUGR fetusessymmetrical IUGRasymmetrical IUGR

Study Arms (3)

AGA

symmetrical IUGR

asymmetrical IUGR

Eligibility Criteria

Age28 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pregnant women 28-37 GA, singleton, otherwise normal fetuses

You may qualify if:

  • singleton,
  • GA,
  • well dated pregnancy.

You may not qualify if:

  • multifetal pregnancies,
  • no first trimester dating,
  • fetuses with known chromosomal or structural anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2010

First Posted

August 10, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 28, 2013

Record last verified: 2013-08