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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Roma La Sapienza

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

366 Participants
are grouped into 2 trial groups
Group A: Hypertensive disorders of pregnancy
Group B: Normotensive comparison group

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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