NCT07258329

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2025Oct 2028

Study Start

First participant enrolled

March 28, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

November 19, 2025

Last Update Submit

November 26, 2025

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of Participants With Fetal Acidosis (pH ≤ 7.0 or Base Excess ≥ -12)

    At the time of delivery

  • Number of Participants With 5-Minute Apgar Score < 7

    At the time of delivery

  • Number of Newborns Transferred to Neonatal Intensive Care Unit (NICU) for Birth-Related Hypoxia

    At the time of delivery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

NOT YET RECRUITING

Central Study Contacts

Antonio Farina, MD

CONTACT

0512144377antonio.farina@unibo.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 2, 2025

Study Start

March 28, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations

IT(2)