Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT07211503
Eligibility Criteria:
Inclusion Criteria:
SOFI case group:
* Women with gestational age \>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.
* Single fetus in cephalic presentation
* Age ≥18 years
* Presence of CTG characteristics associated with fetal inflammation/infection (fetal heart rate (fetal heart rate (FHR) \>150 bpm with gestational age \>40 weeks or a 10% increase in FHR, absence of cycling, fetal tachycardia \>=160 bpm, variability \<5 bpm)
* Signed informed consent form by the patient.
NEFI control group:
* Women with gestation \>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.
* Single fetus in cephalic presentation.
* Age ≥18 years.
* Patients with a CTG tracing that does not show features associated with fetal inflammation/infection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm).
* Patient signed informed consent form.
Exclusion Criteria:
* Failure to sign informed consent
* Intrauterine fetal death
* Congenital fetal and/or chromosomal abnormalities
* Maternal cardiac abnormalities and/or cardiac therapy and/or therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin)
* Twin or multiple pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07211503
Study Brief:
Protocol Section:
NCT07211503