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

July 3, 2020 updated by: Petar Ignatov, Orthogyn Medical Center, Bulgaria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Bulgarian population (caucasian)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthogyn Medical Center, Bulgaria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2011

Primary Completion (Actual)

October 7, 2019

Study Completion (Actual)

October 7, 2019

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QDSP Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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