Screening for Intrapartum Fetal Compromise Using Placental Biomarkers
ConditionPregnant Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
This study aims to investigate the association between placental markers (sFlt-1, PlGF, and the sFlt-1/PlGF ratio) and intrapartum fetal compromise, assessed on the basis of the cardiotocographic tracing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Gestational age ≥ 32 weeks
Obtaining informed consent for participation in the study and for the processing of personal data
Pregnant patients with an indication to perform placental marker testing as part of routine clinical practice
Disqualifiers
None
Trial population
The study will enroll pregnant patients who present to the Obstetrics Units of the participating centers
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of Participants Diagnosed with Intrapartum Fetal Compromise Based on Cardiotocographic Tracing
Association between placental markers and intrapartum fetal compromise
Time frame
At the time of deliverySecondary outcomes
1
Number of Participants With Fetal Acidosis (pH ≤ 7.0 or Base Excess ≥ -12)
Association between placental markers and fetal acidosis
Time frame
At the time of delivery2
Number of Participants With 5-Minute Apgar Score < 7
Association between placental markers and low birth Apgar score
Time frame
At the time of delivery3
Number of Newborns Transferred to Neonatal Intensive Care Unit (NICU) for Birth-Related Hypoxia
Association between placental markers and admission to the neonatal intensive care unit
Time frame
At the time of deliverySponsors and contacts
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Source ClinicalTrials.gov