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

Study acronym: OPHELIA
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07846137
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Ophthalmic Artery, Labor and Delivery, Induction of Labor, Intrapartum Fetal Distress, Optic Nerve Sheath Diameter Measurement, Doppler Ultrasound, Placental Insufficiency
Related terms Placental Insufficiency
Enrollment 1,477 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov