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NOT YET RECRUITING
NCT07846137
NA

The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The ophthalmic artery Doppler has been recently proposed as a potential "soft marker" for placental insufficiency in retrospective and observational studies, with similar clinical significance with respect to Uterine Artery (UA) Doppler evaluation and it is currently being investigated as an adjunctive clinical instrument to predict pre-eclampsia (PE) occurrence. Placental insufficiency strictly correlates with intrapartum fetal adverse outcomes and a concomitant induction of labor, alone, may further increase the hypoxic stress on the fetus during labor. This can be reflected by cardiotocographic alterations during labor, ultimately leading to emergency cesarean deliveries or instrumental vaginal deliveries. Despite great advancements in understanding various maternal-fetal pathologies, the investigators are still not able to properly detect fetuses that are at higher risk for intrapartum compromise among those receiving an induction of labor. Therefore, the aim of this prospective study is to investigate any potential association between altered ophthalmic artery Doppler PSV ratio measured before labor induction in at-term, pregnant patients with intra-partum fetal compromise. Furthermore, the investigators aim to also measure an additional parameter that is the optic nerve sheath diameter (ONSD) - an indirect measure of intracranial pressure - before and after the second stage of labour, with the aim of studying its physiology during and after delivery.

Official title: OPHthalmic artEry DoppLer Evaluation After 37 Weeks of Gestation and Intrapartum Fetal Adverse Outcomes (the OPHELIA Study)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1477

Start Date

2026-09-24

Completion Date

2027-04-30

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Ophthalmic Artery Doppler

Right before labour induction, once the patient is already admitted into the inpatient ward - as an elective admission for scheduled labour induction - we will perform an ultrasound by gently applying the probe onto the eyelid of the patient, using sterile gel. We will then measure both the Doppler velocity of the Ophthalmic Artery as well as the Optic Nerve Sheath Diameter (ONSD). The ONSD will then be measured again right after delivery following the exact same procedure.