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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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