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Clinical Trials/NCT04447248
NCT04447248
Completed
Not Applicable

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

Orthogyn Medical Center, Bulgaria0 sites1,714 target enrollmentMay 5, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Late-onset Fetal Growth Restriction
Sponsor
Orthogyn Medical Center, Bulgaria
Enrollment
1714
Primary Endpoint
Occurence of hypoxia (pH<7.20) at birth
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 5, 2011
End Date
October 7, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Orthogyn Medical Center, Bulgaria
Responsible Party
Principal Investigator
Principal Investigator

Petar Ignatov

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

Orthogyn Medical Center, Bulgaria

Eligibility Criteria

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

Outcomes

Primary Outcomes

Occurence of hypoxia (pH<7.20) at birth

Time Frame: up to 5 minutes after delivery

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