qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses

NCT ID: NCT04447248

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1714 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-05

Study Completion Date

2019-10-07

Brief Summary

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To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH \< 7.20) among late-onset growth restricted (SGR) fetuses

Detailed Description

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Conditions

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Late-onset Fetal Growth Restriction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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QDSP Protocol

Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* estimated fetal weight below the 10th centile of the reference curve for the Bulgarian population (11);
* absence of sonographic and laboratory evidence of structural anomalies;
* absence of severe maternal complications;
* documented birth weight \< 10th centile;
* full follow-up documentation

Exclusion Criteria

* multiple pregnancies;
* congenital malformations and any chromosomal malformations known before labor and delivery;
* severe maternal complications;
* documented birth weight \> 10th centile;
* pregnancy loss;
* failure to obtain full follow-up documentation
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Orthogyn Medical Center, Bulgaria

OTHER

Sponsor Role lead

Responsible Party

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Petar Ignatov

Assist. Prof. Petar Ignatov, MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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QDSP Protocol

Identifier Type: -

Identifier Source: org_study_id

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