Development of a Predictive Model of Fetal PH At Birth from Novel Variables Derived from Cardiotocographic Tracing
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Antonio Farina, MD
- Phone Number: 0512143110
- Email: antonio.farina@unibo.it
Study Locations
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-
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Bologna, Italy, 40138
- Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
-
Contact:
- Antonio Farina, MD
- Phone Number: 0512143110
- Email: antonio.farina@unibo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fetal acidosis
Time Frame: During delivery
|
pH value ≤ 7.10
|
During delivery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Farina, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pH-CTG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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