Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)

NCT07841795 | Not Yet Recruiting

• 1 other identifier: OPHELIA-PP-2026
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertensive disorders of pregnancy frequently fail to resolve at delivery. A substantial proportion of women remain hypertensive at the six-week postnatal review, postpartum eclampsia occurs days to weeks after birth, and a minority show persisting renal dysfunction. Attendance at postnatal follow-up is nonetheless poor and specialist resources are limited, so a simple bedside test that identified the women whose cardiovascular recovery is incomplete would allow surveillance to be targeted. Ophthalmic artery Doppler is non-invasive, takes about five minutes and requires only a linear transducer already present in obstetric units. Its antenatal performance is well characterised, but a systematic review by this group (PROSPERO CRD420261488689) identified only three studies in thirty years addressing the postpartum period, two of which included a normotensive comparator, totalling 131 women. None reported a threshold or any measure of diagnostic accuracy, and none recorded antihypertensive treatment at the time of scanning. This prospective cohort study will measure ophthalmic artery Doppler indices at four timepoints between delivery and three months in women with hypertensive disorders of pregnancy and in normotensive controls, and will determine whether the peak systolic velocity ratio measured 24 to 48 hours after delivery predicts persistent hypertension at the six-week postnatal review.

Conditions

Hypertensive Disorders of Pregnancy; Pre-eclampsia; Postpartum Hypertension; Puerperal Disorders; Maternal Haemodynamics

Keywords

ophthalmic artery; Doppler ultrasonography; postpartum period; pre-eclampsia; peak systolic velocity ratio; ; postnatal follow-up

Outcome Measures

Primary Outcomes (1)

• Accuracy of ophthalmic artery peak systolic velocity ratio for persistent postpartum hypertension

  Accuracy of the ophthalmic artery peak systolic velocity ratio measured 24-48 hours after delivery for the prediction of persistent postpartum hypertension. Description: area under the receiver operating characteristic curve, with the optimal threshold and its sensitivity and specificity. Persistent hypertension is defined as systolic blood pressure at or above 140 mmHg and/or diastolic at or above 90 mmHg in the absence of antihypertensive treatment, or at or above 130/80 mmHg while on treatment. Time frame: outcome ascertained at six weeks (42 ± 7 days) postpartum.

  Six weeks (42 +/- 7 days) after delivery

Secondary Outcomes (8)

• Difference in ophthalmic artery Doppler indices between cohorts24-48 hours, 7-10 days, 6 weeks and 3 months postpartum

  24-48 hours, 7-10 days, 6 weeks and 3 months postpartum

• Accuracy of peak systolic velocity ratio for postpartum renal dysfunction

  6 weeks after delivery

• Accuracy of peak systolic velocity ratio for readmission for hypertension

  6 weeks after delivery

• Accuracy of peak systolic velocity ratio for escalation of antihypertensive treatment

  6 weeks after delivery

• Ophthalmic Artery Peak Systolic Velocity Ratio in Women Receiving Versus Not Receiving Antihypertensive Treatment

  24-48 hors after delivery

Study Arms (2)

Hypertensive disorders of pregnancy

Women whose pregnancy was complicated by a hypertensive disorder diagnosed by ISSHP 2018 criteria - pre-eclampsia, gestational hypertension, chronic hypertension, chronic hypertension with superimposed pre-eclampsia, eclampsia or HELLP syndrome - or who developed de novo postpartum hypertension or pre-eclampsia within 48 hours of delivery after a normotensive pregnancy. Recruited consecutively after delivery at a participating centre, at any gestational age and by any mode of delivery. Ophthalmic artery Doppler is performed at 24-48 hours, 7-10 days, six weeks and three months postpartum, with a telephone follow-up at six months. Blood pressure is measured at each visit and renal function assessed at six weeks. Doppler results are not disclosed to the clinicians responsible for care.

Normotensive comparison group

Women with a normotensive pregnancy and no hypertensive complication, recruited concurrently at the same centres in a 1:2 ratio relative to the exposed cohort and matched by age band and parity. They undergo the same ophthalmic artery Doppler protocol at the same timepoints, with the same blood pressure measurement procedure, and serve as the reference group for the comparison of Doppler indices during the puerperium.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women delivering at participating tertiary obstetric centres, comprising those whose pregnancy was complicated by a hypertensive disorder or who developed de novo postpartum hypertension, and a concurrently enrolled comparison group of women with normotensive pregnancies.

You may qualify if:

• Exposed Cohort
• Age 18 years or older
• Hypertensive disorder of pregnancy diagnosed by ISSHP 2018 criteria: pre-eclampsia, gestational hypertension, chronic hypertension, chronic hypertension with superimposed pre-eclampsia, eclampsia or HELLP syndrome
• Or de novo postpartum hypertension or pre-eclampsia arising within 48 hours of delivery after a normotensive pregnancy
• Delivery at a participating centre, at any gestational age and by any mode of delivery
• Written informed consent
• Comparison cohort:
• Age 18 years or older
• Normotensive pregnancy without hypertensive complications
• Delivery at a participating centre
• Written informed consent
• Enrolled concurrently at a 1:2 ratio relative to the exposed cohort, matched by age band and parity

You may not qualify if:

• Known ocular disease affecting the orbital circulation: glaucoma, proliferative retinopathy, previous orbital surgery or ocular trauma
• Known carotid artery stenosis or previous cerebrovascular event
• Significant structural heart disease
• Known chronic kidney disease stage 3 or above
• Diabetes mellitus with end-organ damage
• Inability to undergo the examination because of clinical instability or refusal
• Foreseeable inability to complete follow-up
• Inability to give informed consent

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Department of Maternal and Child Health and Urological Sciences

Roma, RM, 00161, Italy

Location

Related Publications (4)

• de Oliveira CA, de Sa RA, Velarde LG, da Silva FC, doVale FA, Netto HC. Changes in ophthalmic artery Doppler indices in hypertensive disorders during pregnancy. J Ultrasound Med. 2013 Apr;32(4):609-16. doi: 10.7863/jum.2013.32.4.609.

  PMID: 23525385 BACKGROUND

• Lau KG, Baloi M, Dumitrascu-Biris D, Nicolaides KH, Kametas NA. Changes in ophthalmic artery Doppler during acute blood-pressure control in hypertensive pregnant women. Ultrasound Obstet Gynecol. 2022 Feb;59(2):185-191. doi: 10.1002/uog.23755.

  PMID: 34358385 BACKGROUND

• Alves Borges JH, Goes DA, de Araujo LB, Dos Santos MC, Debs Diniz AL. Prospective study of the hemodynamic behavior of ophthalmic arteries in postpartum preeclamptic women: A doppler evaluation. Hypertens Pregnancy. 2016;35(1):100-11. doi: 10.3109/10641955.2015.1116553. Epub 2016 Feb 6.

  PMID: 26852911 BACKGROUND

• Giannina G, Belfort MA, Cruz AL, Herd JA. Persistent cerebrovascular changes in postpartum preeclamptic women: a Doppler evaluation. Am J Obstet Gynecol. 1997 Nov;177(5):1213-8. doi: 10.1016/s0002-9378(97)70042-5.

  PMID: 9396921 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Puerperal Disorders

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Giuseppe Rizzo, Prof

CONTACT

39 06 49971; giuseppe.rizzo@uniroma1.it

Ilenia Mappa, Prof

CONTACT

39 06 444971; ilenia.mappa@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the main results and ending 5 years thereafter.
• Access Criteria: Proposals should be directed to the corresponding author. Requesters will be asked to sign a data access agreement specifying the analyses to be performed, the intended publication and the prohibition of any attempt at re-identification. Approval by the steering committee is required. Data will be shared through a secure institutional transfer.

Locations

IT (1)