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NCT05295667 Clinical Trial

Doppler and AFV for Outcome Prediction ın FGR

Fetal Growth Retardation Clinical Trial

Official title:
Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05295667
Other study ID # Besimoglu01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 30, 2020

Study information
Verified date March 2022
Source Istanbul Bakirkoy Maternity and Children Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 30, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - SINGLETON PREGNANCIES WITH FGR FETUSES - AFTER 37th GESTATIONAL WEEKS Exclusion Criteria: - SINGLE OR MUTIPL FETAL ANOMALIES - EVIDENCE OF INTRAUTERINE ENFECTION

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Doppler measurement in combination with amniotic fluid volume
Ultrasonographic evaluation

Locations
Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Bakirkoy Maternity and Children Diseases Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. 2020 Jul 28. doi: 10.1055/a-1205-0161. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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