Doppler and AFV for Outcome Prediction ın FGR

• Sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05295667
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Days): 29
• Patients Per Site Per Month: 105

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fetal Growth Retardation	Diagnostic Test: Doppler measurement in combination with amniotic fluid volume

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Fetal Growth Retardation Group	Diagnostic Test: Doppler measurement in combination with amniotic fluid volume; Ultrasonographic evaluation

Outcome Measures

Primary Outcome Measures

1. the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR) [1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

• SİNGLETON PREGNANCİES WİTH FGR FETUSES

• AFTER 37th GESTATİONAL WEEKS

Exclusion Criteria:

• SİNGLE OR MUTİPL FETAL ANOMALİES

• EVİDENCE OF İNTRAUTERİNE ENFECTİON

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06810

Sponsors and Collaborators

• Istanbul Bakirkoy Maternity and Children Diseases Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Osman Aşıcıoğlu, Associated Proffesor, Istanbul Bakirkoy Maternity and Children Diseases Hospital
• ClinicalTrials.gov Identifier: NCT05295667
• Other Study ID Numbers: Besimoglu01
• First Posted: Mar 25, 2022
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fetal Growth Retardation

Study Results

No Results Posted as of Mar 25, 2022