Ophthalmic Artery Doppler in the Puerperium and Maternal Outcomes After Hypertensive Disorders of Pregnancy: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Accuracy of ophthalmic artery peak systolic velocity ratio for persistent postpartum hypertension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Diabetes mellitus with end-organ damage
- •Inability to undergo the examination because of clinical instability or refusal
- •Foreseeable inability to complete follow-up
- •Inability to give informed consent
研究组 & 干预措施
Hypertensive disorders of pregnancy
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.
Normotensive comparison group
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.
结局指标
主要结局
Accuracy of ophthalmic artery peak systolic velocity ratio for persistent postpartum hypertension
时间窗: Six weeks (42 +/- 7 days) after delivery
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.
次要结局
- Difference in ophthalmic artery Doppler indices between cohorts24-48 hours, 7-10 days, 6 weeks and 3 months postpartum(24-48 hours, 7-10 days, 6 weeks and 3 months postpartum)
- Accuracy of peak systolic velocity ratio for postpartum renal dysfunction(6 weeks after delivery)
- Accuracy of peak systolic velocity ratio for readmission for hypertension(6 weeks after delivery)
- Accuracy of peak systolic velocity ratio for escalation of antihypertensive treatment(6 weeks after delivery)
- Ophthalmic Artery Peak Systolic Velocity Ratio in Women Receiving Versus Not Receiving Antihypertensive Treatment(24-48 hors after delivery)
- Correlation Between Ophthalmic Artery Peak Systolic Velocity Ratio and Time Since Last Antihypertensive Dose(24-48 hours after delivery)
- Difference in Doppler indices between hypertensive phenotypes(6 weeks after delivery)
- Intra- and inter-observer reproducibility of the measurement(Throughout the study period,)
研究者
Giuseppe Rizzo
Prof
University of Roma La Sapienza