Using placental blood markers to detect fetal stress during labor
Official title: Screening Della Compromissione Fetale Intrapartum Mediante Utilizzo Dei Marcatori Placentari
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07258329 · Data updated 2026-11-12
This study will test whether levels of placental markers (sFlt-1, PlGF, and their ratio) can help predict which pregnant people (≥32 weeks) may experience fetal distress during labor.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 428 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Status | Recruiting |
| Started | March 28, 2025 |
| Main results expected | February 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | December 2, 2025 |
| Trial ID | NCT07258329 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant people aged 18 or older, at or beyond 32 weeks gestation, who are having placental marker testing as part of routine care and plan to deliver at a participating center.
✕Probably not a fit
Patients with absolute contraindications to vaginal delivery (e.g., placenta previa, vasa previa, placenta accreta, prior myomectomy) or those who will not deliver at a participating center are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will measure placental biomarkers (sFlt-1, PlGF, and the sFlt-1/PlGF ratio) in pregnant people from 32 weeks gestation and compare those values with cardiotocographic fetal heart tracings during labor. Blood samples and routine fetal monitoring data will be collected from patients who are already undergoing placental marker testing as part of clinical care. Investigators will look for associations between marker levels and signs of intrapartum fetal compromise such as abnormal heart rate patterns or meconium. The study is conducted at participating obstetrics units in Bologna and Milan and uses existing clinical workflows to minimize extra procedures.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify fetuses at higher risk of distress during labor so they can plan closer monitoring or earlier intervention.
How similar studies have gone: Previous work on Doppler measures and placental biomarkers at term has shown modest and sometimes conflicting predictive value, so the approach is promising but not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting -
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy Not yet recruiting
Study contacts
- Study coordinator: Antonio Farina, MD
- Email: antonio.farina@unibo.it
- Phone: 0512144377
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.