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

Quantitative Cardiotocography and Doppler Ultrasound in the Detection of Hypoxia Among Growth-restricted Fetuses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04447248
Enrollment
1714
Registered
2020-06-25
Start date
2011-05-05
Completion date
2019-10-07
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-onset Fetal Growth Restriction

Brief summary

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

Interventions

DEVICEQDSP Protocol

Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Sponsors

Orthogyn Medical Center, Bulgaria
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Occurence of hypoxia (pH<7.20) at birthup to 5 minutes after delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026