Skip to main content
OpenTrials
Completed

NCT Number: NCT04447248

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Late-onset Fetal Growth Restriction

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QDSP Protocol

Device

Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Primary outcomes

  1. Occurence of hypoxia (pH<7.20) at birth

    Time frame: up to 5 minutes after delivery

Sponsors and collaborators

Lead sponsor

Orthogyn Medical Center, Bulgaria

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.