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

NCT07846137 | Not Yet Recruiting

• 1 other identifier: 27393
• Study Type: interventional
• Target: 1,477
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

ophthalmic artery Doppler; induction of labor; intrapartu fetal compromise; placental insufficiency; optic nerve sheath diameter; ONSD

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of labor induction until delivery, up to 72 hours.

Secondary Outcomes (6)

• instrumental vaginal delivery for fetal hypoxic stress

  From start of labor induction until delivery, up to 72 hours.

• Cesarean delivery for any indication

  From start of labor induction until delivery, up to 72 hours.

• Cesarean delivery for clinical or subclinical chorioamnionitis

  From start of labor induction until delivery, up to 72 hours.

• Umbilical arterial pH <7.0

  At delivery

• 5-minute Apgar score <7

  5 minutes after birth

Other Outcomes (1)

• Change in Optic Nerve Sheath Diameter (ONSD)

  Before labor induction and up to 30 minutes after delivery

Study Arms (1)

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.

Diagnostic Test: Ophthalmic Artery Doppler

Interventions

Ophthalmic Artery Doppler DIAGNOSTIC_TEST

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.

Also known as: Optic Nerve Sheath Diameter Assessment

Ophthalmic Artery Doppler Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Pregnant patients after 37 weeks of gestation undergoing induction of labor
• Ability to provide written informed consent

You may not qualify if:

• Age \<18 years
• Known fetal malformations
• Known fetal genetic syndromes
• Multiple pregnancy
• Known maculopathies
• Inability or unwillingness to provide written informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (14)

• 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.

  PMID: 29628552 BACKGROUND

• Berty 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.

  PMID: 36889743 BACKGROUND

• Rossi 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.

  PMID: 31567446 BACKGROUND

• Ghi 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.

  PMID: 39107951 BACKGROUND

• di 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.

  PMID: 38574856 BACKGROUND

• Ali 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.

  PMID: 39831889 BACKGROUND

• Gurgel 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.

  PMID: 26030678 BACKGROUND

• Arechvo 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.

  PMID: 37902727 BACKGROUND

• Cao 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.

  PMID: 38805623 BACKGROUND

• Abdel 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.

  PMID: 35000242 BACKGROUND

• Nicolaides 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.

  PMID: 34292158 BACKGROUND

• Kalafat 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.

  PMID: 29330892 BACKGROUND

• Sapantzoglou 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.

  PMID: 33142353 BACKGROUND

• Sarno 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.

  PMID: 33073902 BACKGROUND

MeSH Terms

Conditions

Placental Insufficiency

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tullio Ghi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tullio Ghi, MD PhD

CONTACT

+393385070025; tullio.ghi@unicatt.it

Alessandro Petrecca, MD

CONTACT

+393479212418; alessandro.petrecca@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Tullio Ghi, MD PhD

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 29, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share