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

Completed

• Conditions: Late-onset Fetal Growth Restriction

• Registration Number: NCT04447248
• Lead Sponsor: Orthogyn Medical Center, Bulgaria

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-05
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-03
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1714

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of hypoxia (pH<7.20) at birth	up to 5 minutes after delivery