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

Study acronym: OPHELIA-PP
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07841795
Lead Sponsor University of Roma La Sapienza
Conditions
(from sponsor)
Hypertensive Disorders of Pregnancy, Pre-eclampsia, Postpartum Hypertension, Puerperal Disorders, Maternal Haemodynamics
Related terms Pre-Eclampsia, Puerperal Disorders
Enrollment 366 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov