An observational study in Hypertensive Disorders of Pregnancy, Pre-eclampsia and Postpartum Hypertension, sponsored by University of Roma La Sapienza. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Roma La Sapienza · Observational
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.
Design. Prospective observational cohort study with consecutive recruitment and a concurrently enrolled normotensive comparison group, conducted at a coordinating tertiary centre and participating satellite centres.
Non-interventional nature. Ophthalmic artery Doppler does not alter clinical management, which follows existing institutional protocols throughout. Doppler results are not communicated to the clinicians responsible for the participant, who remain blinded to them for the duration of the study, so that the measurement cannot influence the outcome it is intended to predict. An alerting procedure is nonetheless in place for incidental findings of clinical relevance.
Assessments. Ophthalmic artery Doppler is performed at 24 to 48 hours (T0), 7 to 10 days (T1), six weeks (T2) and three months (T3) after delivery, with a telephone follow-up at six months (T4). Blood pressure is measured at each visit using a standardised protocol with a validated automated device. Estimated glomerular filtration rate and albumin-to-creatinine ratio are obtained at six weeks.
Doppler protocol. Participants are examined supine with the eyes closed after five minutes of rest. A 7.5-9 MHz linear transducer is placed on the closed upper eyelid without pressure on the globe. The ophthalmic artery is identified superior and medial to the optic nerve, 10-15 mm from the posterior scleral wall. Pulsed-wave sampling uses an insonation angle below 20 degrees, a 2 mm sample gate, a 50 Hz wall filter and a depth of 3.0-4.5 cm, with mechanical index kept at or below 0.3 and insonation time under one minute per eye in accordance with the ALARA principle. Three to five consecutive waveforms of similar morphology are recorded, two cycles are measured per eye, both eyes are examined, and the mean of the two eyes is analysed. First and second peak systolic velocities, their ratio, end-diastolic velocity, resistance index, pulsatility index and mean velocity are recorded.
Antihypertensive exposure. The drug, dose and the interval in minutes between the last administration and the Doppler examination are recorded at every timepoint. This addresses the principal methodological limitation of the existing literature, in which no comparative study documented treatment at the time of scanning although these agents are known to modify the waveform acutely.
Reproducibility. A random 10% sample of examinations is independently re-read by a second blinded operator.
Sample size. The calculation is driven by the precision of the sensitivity estimate for the primary outcome. Assuming a sensitivity of 80% estimated with a 95% confidence interval half-width of 10%, 62 women with the outcome are required; at an anticipated prevalence of persistent hypertension of 30%, this requires 207 women assessed at six weeks, and 244 to be enrolled allowing for 15% attrition. The comparison group of 122 normotensive women gives 90% power at alpha 0.05 to detect a standardised mean difference of 0.40, well below the effects reported in the existing comparative studies.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 366 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exposed Cohort
Comparison cohort:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: Six weeks (42 +/- 7 days) after delivery
Difference in ophthalmic artery Doppler indices between cohorts24-48 hours, 7-10 days, 6 weeks and 3 months postpartum
Difference between women with hypertensive disorders of pregnancy and normotensive women in first peak systolic velocity, second systolic peak, peak systolic velocity ratio, end-diastolic velocity, resistance index, pulsatility index and mean velocity, expressed as adjusted mean differences and as standardised mean differences for comparability with the published literature.
Time frame: 24-48 hours, 7-10 days, 6 weeks and 3 months postpartum
Accuracy of peak systolic velocity ratio for postpartum renal dysfunction
Area under the receiver operating characteristic curve, sensitivity and specificity of the peak systolic velocity ratio measured 24-48 hours after delivery for renal dysfunction, defined as estimated glomerular filtration rate below 60 mL/min/1.73 m2 and/or urinary albumin-to-creatinine ratio above 3 mg/mmol.
Time frame: 6 weeks after delivery
Accuracy of peak systolic velocity ratio for readmission for hypertension
Area under the receiver operating characteristic curve, sensitivity and specificity of the peak systolic velocity ratio for unplanned readmission for hypertension or its complications, including postpartum pre-eclampsia and eclampsia.
Time frame: 6 weeks after delivery
Accuracy of peak systolic velocity ratio for escalation of antihypertensive treatment
Area under the receiver operating characteristic curve, sensitivity and specificity of the peak systolic velocity ratio for the need to start, increase or add antihypertensive medication after discharge.
Time frame: 6 weeks after delivery
Ophthalmic Artery Peak Systolic Velocity Ratio in Women Receiving Versus Not Receiving Antihypertensive Treatment
Peak systolic velocity ratio (second to first systolic peak, unitless) measured by transorbital pulsed-wave Doppler ultrasound as the mean of both eyes, reported separately for women receiving and women not receiving antihypertensive medication at the time of the examination.
Time frame: 24-48 hors after delivery
Correlation Between Ophthalmic Artery Peak Systolic Velocity Ratio and Time Since Last Antihypertensive Dose
Spearman correlation coefficient (unitless, range -1 to 1) between the peak systolic velocity ratio measured by transorbital pulsed-wave Doppler ultrasound and the interval in minutes between the last administration of antihypertensive medication and the Doppler examination, in women receiving treatment.
Time frame: 24-48 hours after delivery
Difference in Doppler indices between hypertensive phenotypes
Comparison of ophthalmic artery indices between pre-eclampsia, gestational hypertension, chronic hypertension and de novo postpartum hypertension, and between severe and non-severe disease.
Time frame: 6 weeks after delivery
Intra- and inter-observer reproducibility of the measurement
Reproducibility of the ophthalmic artery measurement in the postpartum setting, expressed as intraclass correlation coefficient and Bland-Altman limits of agreement, assessed on a random 10% sample independently re-read by a second blinded operator.
Time frame: Throughout the study period,
Plan to share: Yes — De-identified individual participant data underlying the published results, together with the data dictionary, the study protocol, the statistical analysis plan and the analysis code, will be made available to investigators whose proposed use of the data has been approved by the study steering committee.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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