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Clinical Trials in Italy / NCT07841795
Starting soon Observational

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

NCT07841795 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Roma La Sapienza
Phase
Observational
Started
2027-01-01
Last updated
2026-09-25

Condition(s) studied

Hypertensive Disorders of PregnancyPre-eclampsiaPostpartum HypertensionPuerperal DisordersMaternal Haemodynamics

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Accuracy of ophthalmic artery peak systolic velocity ratio for persistent postpartum hypertension — Six weeks (42 +/- 7 days) after delivery
    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.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07841795 on ClinicalTrials.gov ↗ ← All trials in Italy