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NCT Number: NCT06720363

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Antonio Farina, MD

CONTACT

[email protected]

0512143110

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Fetal acidosis

    Time frame: During delivery

    pH value ≤ 7.10

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Farina, MD

CONTACT

[email protected]

0512143110

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

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.

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