qCTG and Doppler Ultrasound in the Detection of Hypoxia A... | NCT04447248

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

NCT04447248

Sponsor

Orthogyn Medical Center, Bulgaria

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

1,714Actual

Phase

Not provided

Conditions

Late-onset Fetal Growth Restriction

Interventions

QDSP Protocol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2011Actual

Primary Completion Date

Oct 7, 2019Actual

Completion Date

Oct 7, 2019Actual

First Submitted Date

Jun 23, 2020

First Submission Date that Met QC Criteria

Jun 23, 2020

First Posted Date

Jun 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2020

Last Update Posted Date

Jul 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Petar Ignatov, Assist. Prof. Petar Ignatov, MD, Ph.D., Orthogyn Medical Center, BulgariaPrincipal Investigator

Lead Sponsor

Orthogyn Medical Center, BulgariaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,714Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QDSP Protocol	Device	Computerized expert system for fetal monitoring, based on cardiotocogrpaphy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of hypoxia (pH<7.20) at birth		up to 5 minutes after delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Bulgarian population (caucasian)

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided