NCT04447248

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2011

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

8.4 years

First QC Date

June 23, 2020

Last Update Submit

July 3, 2020

Conditions

Late-onset Fetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Occurence of hypoxia (pH<7.20) at birth

    up to 5 minutes after delivery

Interventions

QDSP ProtocolDEVICE

Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Bulgarian population (caucasian)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Petar Ignatov, MD, Ph.D.

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 25, 2020

Study Start

May 5, 2011

Primary Completion

October 7, 2019

Study Completion

October 7, 2019

Last Updated

July 7, 2020

Record last verified: 2020-07