Ophthalmic Artery Doppler to predict labor problems before induction
Official title: OPHthalmic artEry DoppLer Evaluation After 37 Weeks of Gestation and Intrapartum Fetal Adverse Outcomes (the OPHELIA Study)
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07846137 · Data updated 2026-11-12
This study tests whether measuring the ophthalmic artery Doppler in pregnant people at term who are being induced can help predict intrapartum fetal distress.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1477 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, rm) |
| Status | Recruiting |
| Started | September 18, 2026 |
| Main results expected | June 15, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07846137 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals aged 18 or older at or beyond 37 weeks of gestation who are planned for induction of labor and able to give informed consent.
✕Probably not a fit
Patients not showing placental dysfunction or not experiencing intrapartum distress may not derive specific benefit from this testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study investigates the ophthalmic artery Doppler as a potential soft marker of placental insufficiency in patients undergoing induction of labor after 37 weeks. By analyzing the Doppler waveform, particularly the PSV2/PSV1 ratio, researchers aim to see if changes correlate with adverse intrapartum fetal outcomes. The trial is conducted at a single Italian center and involves inducing labor under standard obstetric care with careful intrapartum monitoring. The goal is to determine if OA Doppler can complement existing assessments to identify fetuses at higher risk for hypoxic stress during labor.
Why it matters
Potential benefit: If successful, OA Doppler could provide an early, noninvasive indicator of placental insufficiency to help tailor labor management and improve fetal outcomes.
How similar studies have gone: Previous observational studies have suggested OA Doppler may relate to placental dysfunction, but prospective interventional data are limited and further validation is needed.
Who can join: the full rules
Show full inclusion / exclusion 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 \<18 years * Known fetal malformations * Known fetal genetic syndromes * Multiple pregnancy * Known maculopathies * Inability or unwillingness to provide written informed consent
Where it's running
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Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy
Rome, rm, Italy Recruiting
Study contacts
- Principal investigator: Tullio Ghi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Tullio Ghi, MD PhD
- Email: tullio.ghi@unicatt.it
- Phone: +393385070025
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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.