FRI a Method of Reading Cardiotocography (CTG) in Labor

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method called the Fetal Reserve Index (FRI) to help doctors read heart rate patterns of babies during labor, known as cardiotocography (CTG). The goal is to see if using FRI can better identify situations where urgent medical help is needed, which could lead to problems for the baby, compared to the usual way of interpreting CTG.

To participate in the trial, women who are in active labor and have had a normal initial heart rate test but later show concerning heart rate patterns may be eligible. Participants will be randomly assigned to either the FRI group, where doctors will use this new method, or to a control group that follows standard care. Women who have had previous C-sections, are pregnant with twins, or have certain health conditions may not be able to join. If you decide to participate, you will need to sign a consent form, and your safety and comfort will be a priority throughout the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women in the active phase of labor who presented when they entered the room I delivered a negative admission test (i.e. a normoreactive CTG according to ACOG) and that subsequently present during labor a diagnosis of category II CTG
• • Single term pregnancy
• • Signature of informed consent
• • Exclusion criteria
• • Failure to sign the informed consent
• • Previous caesarean section (TOLAC)
• • Twin pregnancy
• • Gestational age \<37 weeks
• • Known genetic/chromosomal syndromes and/or malformations, excluding heart disease without contraindication to vaginal birth
• Exclusion Criteria:
• • -