Ophthalmic ArteryOPHELIANCT07846137
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
A study testing Ophthalmic Artery Doppler in people with Ophthalmic Artery and Labor and Delivery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ophthalmic Artery, Labor and Delivery, Induction of Labor
- What is being tested?
- Ophthalmic Artery Doppler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,477 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Pregnant patients after 37 weeks of gestation undergoing induction of labor
- Ability to provide written informed consent
Who cannot join
- Age <18 years
- Known fetal malformations
- Known fetal genetic syndromes
- Multiple pregnancy
- Known maculopathies
- Inability or unwillingness to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy
Rome, rm, 00168
Alessandro Petrecca, MD, 0039 3479212418, alessandro.petrecca@guest.policlinicogemelli.it
Tullio Ghi, MD, PhD, tullio.ghi@policlinicogemelli.it
About this study
Official title: OPHthalmic artEry DoppLer Evaluation After 37 Weeks of Gestation and Intrapartum Fetal Adverse Outcomes (the OPHELIA Study)
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.
Read the detailed description
The ophthalmic artery (OA) 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. It has been investigated in small-for-gestational-age (SGA) or fetal-growth-restricted (FGR) fetuses, as well as in low-risk pregnancies and at various gestational ages during pregnancy, showing to be predictive of impaired placentation, and, consequently, of pre-eclampsia occurrence.
The OA is the first branch of the internal carotid artery and its Doppler velocity waveform has two systolic peaks. The first systolic wave (PSV1) is created by cardiac systole, with the opening of the aortic valve and ejection of blood into the aorta, whilst the second systolic wave (PSV2) is a reflective wave formed by the systolic pulse wave reaching smaller, higher resistance arterioles and being reflected back towards the heart. At the level of the aortic arch, a fraction is diverted cranially to the cerebral circulation as a forward wave to create PSV2. In this way, PSV2 is most influenced by peripheral arterial compliance and resistance, whilst PSV1 is more affected by cardiac output. Therefore, an increase in the ratio of PSV2 to PSV1 (PSV ratio) could represent an increase in peripheral vascular resistance and/or a reduction in cardiac output, which are both indirect signs of placental dysfunction. The latter can be manifested during labor with well-established cardiotocographic patterns and induction of labor, alone, may enhance the intrapartum hypoxic stress on the fetus.
Furthermore, another parameter that is currently understudy is the Optic Nerve Sheath Diameter (ONSD). Recent evidence suggests that ONSD increases in pre-eclamptic patients, possibly reflecting a transient increase in intracranial pressure. However, evidence is scarce regarding its physiologic changes during and after labour. In understanding the potential mechanisms behind intrapartum fetal compromise in gravid, at-term patients undergoing labor induction, the hypothesis is that placental dysfunction, albeit not necessarily clinically manifest earlier in pregnancy, may play a role in fetal compromise during labor, especially in pregnancies undergoing induction of labor. Hence, investigating potential associations between a "soft marker" of placental insufficiency as Ophthalmic artery Doppler PSV ratio alterations and intrapartum fetal compromise would be paramount. Therefore the aim of this prospective interventional study is to investigate any association with altered OA PSV ratio and intrapartum fetal adverse outcomes in pregnant patients that reach term of pregnancy, undergoing induction of labor. In addition, the investigatos also aim to evaluate the ONSD before and after the second stage of labour in order to study its physiologic changes.
- Conditions
- Ophthalmic Artery, Labor and Delivery, Induction of Labor, Intrapartum Fetal Distress, Optic Nerve Sheath Diameter Measurement, Doppler Ultrasound
- Being tested
- Ophthalmic Artery Doppler
- Keywords
- ophthalmic artery Doppler, induction of labor, intrapartu fetal compromise, placental insufficiency, optic nerve sheath diameter, ONSD
- Medical subject headings
- Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic Artery DopplerDiagnostic test
Also called Optic Nerve Sheath Diameter Assessment
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.
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic Artery Doppler Assessment | Experimental | Pregnant patients after 37 weeks of gestation undergoing induction of labor. Before labor induction, participants will undergo maternal ophthalmic artery Doppler assessment and measurement of optic nerve sheath diameter (ONSD). ONSD will be measured again after delivery. Maternal, intrapartum, and neonatal outcomes will be collected. Receives: Diagnostic Test: Ophthalmic Artery Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Occurrence of cesarean delivery during labor due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: From start of labor induction until delivery, up to 72 hours.
Secondary outcomes (6)
instrumental vaginal delivery for fetal hypoxic stress
Occurrence of instrumental vaginal delivery due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: From start of labor induction until delivery, up to 72 hours.
Cesarean delivery for any indication
Occurrence of cesarean delivery for any indication, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: From start of labor induction until delivery, up to 72 hours.
Cesarean delivery for clinical or subclinical chorioamnionitis
Occurrence of cesarean delivery due to clinical or subclinical chorioamnionitis, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: From start of labor induction until delivery, up to 72 hours.
Umbilical arterial pH <7.0
Occurrence of umbilical arterial cord blood pH <7.0 at delivery, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: At delivery
5-minute Apgar score <7
Occurrence of an Apgar score <7 at 5 minutes after birth, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: 5 minutes after birth
Neonatal Intensive Care Unit admission
Occurrence of neonatal admission to the Neonatal Intensive Care Unit (NICU), evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Measured: From birth until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start18 Sep 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ophthalmic ArteryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,477 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghi Tullio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Tullio Ghi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846137
- Sponsor's protocol ID
- 27393
- Acronym
- OPHELIA
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available.
Publications
Singh SK, Bhatia K. Ultrasonographic Optic Nerve Sheath Diameter as a Surrogate Measure of Raised Intracranial Pressure in Severe Pregnancy-induced Hypertension Patients. Anesth Essays Res. 2018 Jan-Mar;12(1):42-46. doi: 10.4103/aer.AER_218_17.
PubMed 29628552Berty Gutierrez H, Carrera Gonzalez E. Usefulness of optic nerve sheath diameter measurement in hypertensive patients during pregnancy and the puerperium. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2187253. doi: 10.1080/14767058.2023.2187253.
PubMed 36889743Rossi AC, Prefumo F. Antepartum and intrapartum risk factors for neonatal hypoxic-ischemic encephalopathy: a systematic review with meta-analysis. Curr Opin Obstet Gynecol. 2019 Dec;31(6):410-417. doi: 10.1097/GCO.0000000000000581.
PubMed 31567446Ghi T, Fieni S, Ramirez Zegarra R, Pereira S, Dall'Asta A, Chandraharan E. Relative uteroplacental insufficiency of labor. Acta Obstet Gynecol Scand. 2024 Oct;103(10):1910-1918. doi: 10.1111/aogs.14937. Epub 2024 Aug 6.
PubMed 39107951di Pasquo E, Giannubilo SR, Valentini B, Salvi S, Rullo R, Fruci S, Filippi E, Ornaghi S, Zullino S, Rossi F, Farsetti D, Di Martino DD, Vasapollo B, Locatelli A, De Santis M, Ciavattini A, Lanzone A, Mecacci F, Ferrazzi E, Valensise H, Ghi T. The "Preeclampsia and Hypertension Target Treatment" study: a multicenter prospective study to evaluate the effectiveness of the antihypertensive therapy based on maternal hemodynamic findings. Am J Obstet Gynecol MFM. 2024 May;6(5):101368. doi: 10.1016/j.ajogmf.2024.101368. Epub 2024 Apr 3.
PubMed 38574856Ali S, Mukasa DC, Lukakamwa D, Nakayenga A, Namagero P, Biira J, Byamugisha J, Papageorghiou AT. Relationship of maternal ophthalmic artery Doppler with uterine artery Doppler, hemodynamic indices and gestational age: prospective MATERA study. Ultrasound Obstet Gynecol. 2025 Feb;65(2):163-172. doi: 10.1002/uog.29162. Epub 2025 Jan 20.
PubMed 39831889Gurgel Alves JA, Maia e Holanda Moura SB, Araujo Junior E, Tonni G, Martins WP, Da Silva Costa F. Predicting small for gestational age in the first trimester of pregnancy using maternal ophthalmic artery Doppler indices. J Matern Fetal Neonatal Med. 2016;29(7):1190-4. doi: 10.3109/14767058.2015.1040755. Epub 2015 Jun 1.
PubMed 26030678Arechvo A, Wright A, Nobile Recalde A, Liandro R, Charakida M, Nicolaides KH. Ophthalmic artery Doppler and biomarkers of impaired placentation at 36 weeks' gestation in pregnancies with small fetuses. Ultrasound Obstet Gynecol. 2024 Mar;63(3):358-364. doi: 10.1002/uog.27521. Epub 2024 Feb 10.
PubMed 37902727Cao L, He B, Zhou Y, Chen T, Gao Y, Yao B. Utility of uterine artery Doppler ultrasound imaging in predicting preeclampsia during pregnancy: a meta-analysis. Med Ultrason. 2024 Jun 21;26(2):197-204. doi: 10.11152/mu-4355. Epub 2024 Apr 15.
PubMed 38805623Abdel Azim S, Sarno M, Wright A, Vieira N, Charakida M, Nicolaides KH. Ophthalmic artery Doppler at 35-37 weeks' gestation in pregnancies with small or growth-restricted fetuses. Ultrasound Obstet Gynecol. 2022 Apr;59(4):483-489. doi: 10.1002/uog.24854. Epub 2022 Mar 4.
PubMed 35000242Nicolaides KH, Sarno M, Wright A. Ophthalmic artery Doppler in the prediction of preeclampsia. Am J Obstet Gynecol. 2022 Feb;226(2S):S1098-S1101. doi: 10.1016/j.ajog.2020.11.039. Epub 2021 Apr 24.
PubMed 34292158Kalafat E, Laoreti A, Khalil A, Da Silva Costa F, Thilaganathan B. Ophthalmic artery Doppler for prediction of pre-eclampsia: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jun;51(6):731-737. doi: 10.1002/uog.19002. Epub 2018 May 3.
PubMed 29330892Sapantzoglou I, Wright A, Arozena MG, Campos RV, Charakida M, Nicolaides KH. Ophthalmic artery Doppler in combination with other biomarkers in prediction of pre-eclampsia at 19-23 weeks' gestation. Ultrasound Obstet Gynecol. 2021 Jan;57(1):75-83. doi: 10.1002/uog.23528. Epub 2020 Dec 4.
PubMed 33142353Sarno M, Wright A, Vieira N, Sapantzoglou I, Charakida M, Nicolaides KH. Ophthalmic artery Doppler in combination with other biomarkers in prediction of pre-eclampsia at 35-37 weeks' gestation. Ultrasound Obstet Gynecol. 2021 Apr;57(4):600-606. doi: 10.1002/uog.23517. Epub 2021 Mar 15.
PubMed 33073902
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPHthalmic artEry DoppLer Evaluation After 37 Weeks of Gestation and Intrapartum Fetal Adverse Outcomes (the OPHELIA Study)
- ClinicalTrials.gov ID
- NCT07846137
- Acronym / sponsor ID
- OPHELIA / 27393
- Conditions
- Ophthalmic Artery, Labor and Delivery, Induction of Labor, Intrapartum Fetal Distress, Optic Nerve Sheath Diameter Measurement, Doppler Ultrasound
- Keywords
- ophthalmic artery Doppler, induction of labor, intrapartu fetal compromise, placental insufficiency, optic nerve sheath diameter, ONSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,477 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ophthalmic artery (OA) 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. It has been investigated in small-for-gestational-age (SGA) or fetal-growth-restricted (FGR) fetuses, as well as in low-risk pregnancies and at various gestational ages during pregnancy, showing to be predictive of impaired placentation, and, consequently, of pre-eclampsia occurrence.
The OA is the first branch of the internal carotid artery and its Doppler velocity waveform has two systolic peaks. The first systolic wave (PSV1) is created by cardiac systole, with the opening of the aortic valve and ejection of blood into the aorta, whilst the second systolic wave (PSV2) is a reflective wave formed by the systolic pulse wave reaching smaller, higher resistance arterioles and being reflected back towards the heart. At the level of the aortic arch, a fraction is diverted cranially to the cerebral circulation as a forward wave to create PSV2. In this way, PSV2 is most influenced by peripheral arterial compliance and resistance, whilst PSV1 is more affected by cardiac output. Therefore, an increase in the ratio of PSV2 to PSV1 (PSV ratio) could represent an increase in peripheral vascular resistance and/or a reduction in cardiac output, which are both indirect signs of placental dysfunction. The latter can be manifested during labor with well-established cardiotocographic patterns and induction of labor, alone, may enhance the intrapartum hypoxic stress on the fetus.
Furthermore, another parameter that is currently understudy is the Optic Nerve Sheath Diameter (ONSD). Recent evidence suggests that ONSD increases in pre-eclamptic patients, possibly reflecting a transient increase in intracranial pressure. However, evidence is scarce regarding its physiologic changes during and after labour. In understanding the potential mechanisms behind intrapartum fetal compromise in gravid, at-term patients undergoing labor induction, the hypothesis is that placental dysfunction, albeit not necessarily clinically manifest earlier in pregnancy, may play a role in fetal compromise during labor, especially in pregnancies undergoing induction of labor. Hence, investigating potential associations between a "soft marker" of placental insufficiency as Ophthalmic artery Doppler PSV ratio alterations and intrapartum fetal compromise would be paramount. Therefore the aim of this prospective interventional study is to investigate any association with altered OA PSV ratio and intrapartum fetal adverse outcomes in pregnant patients that reach term of pregnancy, undergoing induction of labor. In addition, the investigatos also aim to evaluate the ONSD before and after the second stage of labour in order to study its physiologic changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic Artery Doppler Assessment | Experimental | Diagnostic Test: Ophthalmic Artery DopplerPregnant patients after 37 weeks of gestation undergoing induction of labor. Before labor induction, participants will undergo maternal ophthalmic artery Doppler assessment and measurement of optic nerve sheath diameter (ONSD). ONSD will be measured again after delivery. Maternal, intrapartum, and neonatal outcomes will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Pregnant patients after 37 weeks of gestation undergoing induction of labor
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Age <18 years
- Known fetal malformations
- Known fetal genetic syndromes
- Multiple pregnancy
- Known maculopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmic Artery DopplerAlso: Optic Nerve Sheath Diameter AssessmentRight 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. | Diagnostic test | Ophthalmic Artery Doppler Assessment |
Primary outcome
Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
Time frame: From start of labor induction until delivery, up to 72 hours.
Occurrence of cesarean delivery during labor due to fetal hypoxic stress, evaluated in relation to maternal ophthalmic artery Doppler indices measured before induction of labor.
6 secondary outcomes
instrumental vaginal delivery for fetal hypoxic stress
Time frame: From start of labor induction until delivery, up to 72 hours.
Cesarean delivery for any indication
Time frame: From start of labor induction until delivery, up to 72 hours.
Cesarean delivery for clinical or subclinical chorioamnionitis
Time frame: From start of labor induction until delivery, up to 72 hours.
Umbilical arterial pH <7.0
Time frame: At delivery
5-minute Apgar score <7
Time frame: 5 minutes after birth
Neonatal Intensive Care Unit admission
Time frame: From birth until hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 29628552Singh SK, Bhatia K. Ultrasonographic Optic Nerve Sheath Diameter as a Surrogate Measure of Raised Intracranial Pressure in Severe Pregnancy-induced Hypertension Patients. Anesth Essays Res. 2018 Jan-Mar;12(1):42-46. doi: 10.4103/aer.AER_218_17.
- Background: PubMed 36889743Berty Gutierrez H, Carrera Gonzalez E. Usefulness of optic nerve sheath diameter measurement in hypertensive patients during pregnancy and the puerperium. J Matern Fetal Neonatal Med. 2023 Dec;36(1):2187253. doi: 10.1080/14767058.2023.2187253.
- Background: PubMed 31567446Rossi AC, Prefumo F. Antepartum and intrapartum risk factors for neonatal hypoxic-ischemic encephalopathy: a systematic review with meta-analysis. Curr Opin Obstet Gynecol. 2019 Dec;31(6):410-417. doi: 10.1097/GCO.0000000000000581.
- Background: PubMed 39107951Ghi T, Fieni S, Ramirez Zegarra R, Pereira S, Dall'Asta A, Chandraharan E. Relative uteroplacental insufficiency of labor. Acta Obstet Gynecol Scand. 2024 Oct;103(10):1910-1918. doi: 10.1111/aogs.14937. Epub 2024 Aug 6.
- Background: PubMed 38574856di Pasquo E, Giannubilo SR, Valentini B, Salvi S, Rullo R, Fruci S, Filippi E, Ornaghi S, Zullino S, Rossi F, Farsetti D, Di Martino DD, Vasapollo B, Locatelli A, De Santis M, Ciavattini A, Lanzone A, Mecacci F, Ferrazzi E, Valensise H, Ghi T. The "Preeclampsia and Hypertension Target Treatment" study: a multicenter prospective study to evaluate the effectiveness of the antihypertensive therapy based on maternal hemodynamic findings. Am J Obstet Gynecol MFM. 2024 May;6(5):101368. doi: 10.1016/j.ajogmf.2024.101368. Epub 2024 Apr 3.
- Background: PubMed 39831889Ali S, Mukasa DC, Lukakamwa D, Nakayenga A, Namagero P, Biira J, Byamugisha J, Papageorghiou AT. Relationship of maternal ophthalmic artery Doppler with uterine artery Doppler, hemodynamic indices and gestational age: prospective MATERA study. Ultrasound Obstet Gynecol. 2025 Feb;65(2):163-172. doi: 10.1002/uog.29162. Epub 2025 Jan 20.
- Background: PubMed 26030678Gurgel Alves JA, Maia e Holanda Moura SB, Araujo Junior E, Tonni G, Martins WP, Da Silva Costa F. Predicting small for gestational age in the first trimester of pregnancy using maternal ophthalmic artery Doppler indices. J Matern Fetal Neonatal Med. 2016;29(7):1190-4. doi: 10.3109/14767058.2015.1040755. Epub 2015 Jun 1.
- Background: PubMed 37902727Arechvo A, Wright A, Nobile Recalde A, Liandro R, Charakida M, Nicolaides KH. Ophthalmic artery Doppler and biomarkers of impaired placentation at 36 weeks' gestation in pregnancies with small fetuses. Ultrasound Obstet Gynecol. 2024 Mar;63(3):358-364. doi: 10.1002/uog.27521. Epub 2024 Feb 10.
- Background: PubMed 38805623Cao L, He B, Zhou Y, Chen T, Gao Y, Yao B. Utility of uterine artery Doppler ultrasound imaging in predicting preeclampsia during pregnancy: a meta-analysis. Med Ultrason. 2024 Jun 21;26(2):197-204. doi: 10.11152/mu-4355. Epub 2024 Apr 15.
- Background: PubMed 35000242Abdel Azim S, Sarno M, Wright A, Vieira N, Charakida M, Nicolaides KH. Ophthalmic artery Doppler at 35-37 weeks' gestation in pregnancies with small or growth-restricted fetuses. Ultrasound Obstet Gynecol. 2022 Apr;59(4):483-489. doi: 10.1002/uog.24854. Epub 2022 Mar 4.
- Background: PubMed 34292158Nicolaides KH, Sarno M, Wright A. Ophthalmic artery Doppler in the prediction of preeclampsia. Am J Obstet Gynecol. 2022 Feb;226(2S):S1098-S1101. doi: 10.1016/j.ajog.2020.11.039. Epub 2021 Apr 24.
- Background: PubMed 29330892Kalafat E, Laoreti A, Khalil A, Da Silva Costa F, Thilaganathan B. Ophthalmic artery Doppler for prediction of pre-eclampsia: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jun;51(6):731-737. doi: 10.1002/uog.19002. Epub 2018 May 3.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available.
Related trials for Ophthalmic Artery
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Not yet recruitingObservational study
Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)
Hypertensive Disorders of Pregnancy, Pre-eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tullio Ghi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmic Artery Doppler in people with Ophthalmic Artery and Labor and Delivery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tullio Ghi, MD PhD (+393385070025, tullio.ghi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of in-labor cesarean delivery due to fetal hypoxic stress, assessed in relation to maternal ophthalmic artery Doppler indices measured before induction of labor. (time frame: From start of labor induction until delivery, up to 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07846137, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.