NCT05295667

Brief Summary

The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

Same day

First QC Date

March 8, 2022

Last Update Submit

March 15, 2022

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

  • the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR)

    enterence to neonatal intensive care unit and severe fetal acidemia ( pH: \>7.10)

    1 year

Study Arms (1)

Fetal Growth Retardation Group

Diagnostic Test: Doppler measurement in combination with amniotic fluid volume

Interventions

Doppler measurement in combination with amniotic fluid volumeDIAGNOSTIC_TEST

Ultrasonographic evaluation

Fetal Growth Retardation Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women with fetal growth retardation (FGR)
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A pregnant womens between 18-40 years of age with singleton pregnancy after 37 weeks of gestational age with FGR

You may qualify if:

  • SİNGLETON PREGNANCİES WİTH FGR FETUSES
  • AFTER 37th GESTATİONAL WEEKS

You may not qualify if:

  • SİNGLE OR MUTİPL FETAL ANOMALİES
  • EVİDENCE OF İNTRAUTERİNE ENFECTİON

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06810, Turkey (Türkiye)

Location

Related Publications (1)

  • Stumpfe FM, Faschingbauer F, Kehl S, Pretscher J, Emons J, Gass P, Mayr A, Schmid M, Beckmann MW, Stelzl P. Amniotic-Umbilical-to-Cerebral Ratio - A Novel Ratio Combining Doppler Parameters and Amniotic Fluid Volume to Predict Adverse Perinatal Outcome in SGA Fetuses At Term. Ultraschall Med. 2022 Apr;43(2):159-167. doi: 10.1055/a-1205-0161. Epub 2020 Jul 28.

    PMID: 32722822BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 25, 2022

Study Start

June 1, 2020

Primary Completion

June 1, 2020

Study Completion

June 30, 2020

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)