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

Late-onset Fetal Growth Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447248
• Other study ID #: QDSP Protocol
• Status: Completed
• Start date: May 5, 2011
• Est. completion date: October 7, 2019

Study information

• Verified date: July 2020
• Source: Orthogyn Medical Center, Bulgaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1714
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Hypoxia
• Late-onset Fetal Growth Restriction

Intervention

Device:
• QDSP Protocol
Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orthogyn Medical Center, Bulgaria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of hypoxia (pH<7.20) at birth		up to 5 minutes after delivery