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Recruiting NCT07846137

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

Conditions: Ophthalmic Artery, Labor and Delivery, Induction of Labor, Intrapartum Fetal Distress, Optic Nerve Sheath Diameter Measurement, Doppler Ultrasound, Placental Insufficiency

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1477
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy Rome rm

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.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * Pregnant patients after 37 weeks of gestation undergoing induction of labor * Ability to provide written informed consent Exclusion Criteria: * Age \

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Source: ClinicalTrials.gov (NCT07846137). StuddyBuddy aggregates publicly available trial information.