NCT03962153

Brief Summary

The hypothesis is to increase the predictability of the ultrasound examination evaluating new fetal parameters: in fact the thickness of the soft tissues can contribute significantly to the fetal weight and the characteristics of the thoracic cage may correlate with the fetal weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

May 21, 2019

Last Update Submit

May 22, 2019

Conditions

Fetal Growth Abnormality

Keywords

fetal growthultrasonographic parameters

Outcome Measures

Primary Outcomes (7)

  • biparietal diameter

    Evaluation of biparietal diameter

    9 months

  • head circumference

    evaluation of head circumference

    9 months

  • abdominal circumference

    Evaluation of abdominal circumference

    9 months

  • femur length

    Evaluation of femur length

    9 months

  • transtentorial diameter

    Evaluation of transtentorial diameter

    9 months

  • distance between L1-L4 lumbar vertebrae

    Evaluation of distance between L1-L4

    9 months

  • Fetal Weight

    Evaluation of Fetal Weight

    9 months

Interventions

Obstetric UltrasonographyDIAGNOSTIC_TEST

Obstetric Ultrasonography

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

single pregnancies, free of complications, with delivery completed between 37 and 42 weeks, but within a week of the last ultrasound examination performed. Patients are selected among those candidates with elective caesarean section, pregnant who come to hospital for prodroma of labor and conditions that require induction of childbirth such as prolonged pregnancy or PROM.

You may qualify if:

  • pregnant women

You may not qualify if:

  • fetal structural and / or chromosomal anomalies
  • multiple pregnancies
  • premature births (gestational age \<37w)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Napoli, 80138, Italy

Location

Study Design

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

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

January 1, 2019

Primary Completion

April 18, 2019

Study Completion

April 18, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)