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Development of a Predictive Model of Fetal PH At Birth from Novel Variables Derived from Cardiotocographic Tracing

NCT ID: NCT06720363

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-07

Study Completion Date

2028-08-01

Brief Summary

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The goal of this observational study is to build a predictive model of fetal acidosis based on variables from the cardiotocographic tracing recorded during labor in participants undergoing spontaneous or induced delivery with single pregnancy.

Detailed Description

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Cardiotocography is the current tool used to assess fetal well-being in labor and to identify cases of fetal distress early. We decided to conduct this study because the current interpretation of the cardiotocographic trace has limitations, related to the subjective interpretation of the trace. There are currently no predictive models that can reduce this margin of error. Creating a predictive model of fetal acidosis, based on variables from the cardiotocographic tracing, could be useful in order to enable a better and more timely intervention. It can also be useful in reducing the rate of improper obstetric interventions.

The recording of the cardiotocographic trace will take place throughout the duration of labor as per internal clinical management recommendations. Once delivery has taken place (by cesarean section, obstetric suction or spontaneously), the data derived from the cardiotocographic tracing will be extracted using the Sonicaid Fetal Care Software from the cardiotocograph into a .csv file that will report for each second four measurements of heart rate and intensity of maternal contractions.

The .csv file is converted to a .sav file and the new variables are generated, using a specially created SPSS script, in order to calculate the stability and variability of fetal heart rate. Neonatal outcomes will be considered the dependent variable in this set of variables originated from the fetal heart rate patterns.

The clinical variables that will be collected for the predictive model and/or for descriptive purposes are:

* umbilical artery and vein pH
* excess umbilical artery and vein bases
* Apgar score at birth
* presence of dyed amniotic fluid
* onset of active labor of delivery
* onset of the expulsive period
* fetal expulsion
* cord rounds
* mode of delivery
* neonatal weight.

Conditions

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Pregnancies At Increased Risk of Preterm Birth

Keywords

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Fetal acidosis pH cardiotocography CTG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Maternal age between 18 and 45 years;
* Single pregnancy
* Participants undergoing continuous monitoring of labor labor
* Obtaining informed consent for study participation and processing of personal data

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Farina, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Farina, MD

Role: CONTACT

Phone: 0512143110

Email: [email protected]

Facility Contacts

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Antonio Farina, MD

Role: primary

Other Identifiers

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pH-CTG

Identifier Type: -

Identifier Source: org_study_id