NCT07841795Not yet recruiting
Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)
Ophthalmic Artery Doppler in the Puerperium and Maternal Outcomes After Hypertensive Disorders of Pregnancy: a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 366 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- High blood pressure
- NCT number
- NCT07841795
What you commit to
- Study type: Observational
- Planned participants: 366
- From 1 Jan 2027 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known ocular disease affecting the orbital circulation: glaucoma, proliferative retinopathy, previous orbital surgery or ocular trauma
- Known carotid artery stenosis or previous cerebrovascular event
Other illness
- Significant structural heart disease
- Known chronic kidney disease stage 3 or above
- Diabetes mellitus with end-organ damage
Other
- Inability to undergo the examination because of clinical instability or refusal
- Foreseeable inability to complete follow-up
- Inability to give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero-Universitaria Policlinico Umberto I, Department of Maternal and Child Health and Urological Sciences Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.