Screening for Intrapartum Fetal Compromise Using Placental Biomarkers

Screening Della Compromissione Fetale Intrapartum Mediante Utilizzo Dei Marcatori Placentari

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women

Detailed Description

The development of placentation during pregnancy involves two simultaneous processes: the invasion of maternal spiral arteries by cytotrophoblasts and the branching of the fetal vascular tree. These mechanisms, regulated by factors such as VEGF, PlGF, sFlt-1, and PAPP-A, ensure an adequate supply of oxygen and nutrients to the fetus. When these processes are impaired, placental dysfunction develops, characterized by high vascular resistance, hypoperfusion, and oxidative stress, which can predispose to complications such as preeclampsia, fetal growth restriction, gestational diabetes, placental abruption, and preterm birth.

During labor, uterine contractions can reduce uteroplacental perfusion by up to 60%. A healthy fetus with a normally functioning placenta can tolerate these transient reductions through compensatory mechanisms, whereas a fetus with abnormal placentation may exhibit signs of compromise, such as abnormal heart rate patterns or the presence of meconium, and, in cases of severe hypoxia, may face more serious risks.

The clinical challenge is to identify, before labor, fetuses that, despite appropriate growth, have a placenta unable to withstand the stress of delivery. Some studies have investigated Doppler velocimetry, particularly the Cerebro-Placental Ratio, but its predictive ability at term is modest. The role of placental markers (PlGF, sFlt-1, sFlt-1/PlGF) in predicting intrapartum fetal compromise also remains uncertain, with conflicting results reported in the literature. Since these markers are altered in pregnancies with placental dysfunction, their combination with antenatal risk factors may allow better identification of fetuses at risk, guiding clinicians in labor management and the choice of delivery mode.

This study will enroll participants using a retrospective and prospective approach. The primary aim is to evaluate the association between placental markers and intrapartum fetal compromise based on cardiotocographic tracings. Secondary aims include assessing their relationship with fetal acidosis, low Apgar scores, and admission to the neonatal intensive care unit.

• Study Type: Observational
• Enrollment (Estimated): 428

Contacts and Locations

• Study Contact: Name: Antonio Farina, MD; Phone Number: 0512144377; Email: antonio.farina@unibo.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Antonio Farina, MD; Phone Number: 0512144377; Email: antonio.farina@unibo.it
  • Milano
    • Milan, Milano, Italy, 20122
      • Not yet recruiting
      • IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Contact: Irene Cetin, MD; Phone Number: 0255032240; Email: irene.cetin@unimi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll pregnant patients who present to the Obstetrics Units of the participating centers

Description

Inclusion Criteria:

• 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
• Patients who will deliver at the Obstetrics Units of the participating centers

Exclusion Criteria:

- Absolute contraindications to vaginal delivery (placenta previa, vasa previa, placenta accreta, previous myomectomy)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Diagnosed with Intrapartum Fetal Compromise Based on Cardiotocographic Tracing	Association between placental markers and intrapartum fetal compromise	At the time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Fetal Acidosis (pH ≤ 7.0 or Base Excess ≥ -12)	Association between placental markers and fetal acidosis	At the time of delivery
Number of Participants With 5-Minute Apgar Score < 7	Association between placental markers and low birth Apgar score	At the time of delivery
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	At the time of delivery

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PLGF_IFC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No