Visionary AI Pioneering Diagnostic Tools to Improve Early Detection of Preeclampsia Worldwide
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Hypertensive disorders of pregnancy (HDP) and Preeclampsia (PEC)
研究概览
简要总结
Background and Rationale Hypertensive disorders of pregnancy (HDP), including preeclampsia (PEC), are the second leading cause of maternal deaths worldwide and contribute significantly to preterm birth (PTB), stillbirth and lifelong maternal health complications, including cardiovascular disease, stroke, and vascular dementia.
The pre-eclampsia (PEC) and Hypertensive Disorders of Pregnancies (HDP) and other Adverse Pregnancy Outcomes (APOs) drive maternal and neonatal mortality, accurate low-cost diagnostic methods that are readily deployable in LMIC settings early in pregnancy are largely absent. To address this deficit, our proposal pioneers a high-resolution, non-invasive retinal imaging approach, combined with artificial intelligence (AI), to predict PEC and potentially other APOs early in pregnancy. This approach is grounded in the observation that those at risk for HDP/PEC exhibit increased vascular reactivity on retinal imaging well before clinical detection, as placental and maternal vascular changes begin in the first trimester.1 By integrating retinal vascular imaging and AI-based feature extraction to identify early biomarkers of APO risk, we believe we can accurately discriminate risk as early as the first trimester.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between 18 – 40 years of age.
- •Live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.
- •Intended to deliver within a facility.
排除标准
- •Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation.
- •Subsequent discovery of a fetal anomaly is not viewed as an exclusion.)
- •Inability to obtain any high quality retinal imaging with Optos (i.e., extremely small pupil size, corneal opacities, dense cataracts, vitreous hemorrhage).
- •If one eye is able to be imaged (such as monocular after trauma), this is not viewed as an exclusion.
- •If only Optos wide-field is able to be obtained (such as may happen with small pupil with Remidio), this is not viewed as an exclusion.
- •If a participant is unable to acquire any OPTOS images (better for small pupil than Remidio), she will be deemed ineligible for this study.
- •The number of participants who are not able to be captured by OPTOS is expected to be small, and will be tracked.
- •Unable to provide informed consent, as deemed by site PI.
结局指标
主要结局
Hypertensive disorders of pregnancy (HDP) and Preeclampsia (PEC)
时间窗: Time 1 12 weeks +/- 1 week | Time 2 20 weeks +/-1 week | Time 3 28 0/7 weeks to 32 and 6/7 weeks
次要结局
- Gestational hypertension(New onset after 20 weeks without the development of proteinuria)
- Severe preeclampsia(New onset after 20 weeks without the development of proteinuria)
- Early Onset Preeclampsia(before 34 weeks GA)
- Gestational diabetes(Anytime during pregnancy)
- Vaginal bleeding and /or Antepartum hemorrhage
- Postpartum hemorrhage(After delivery before 6 weeks postpartum)
- Postpartum hypertension(After delivery before 6 weeks postpartum)
- Postpartum infection(After delivery before 6 weeks postpartum)
- Postpartum stroke or heart failure(After delivery before 6 weeks postpartum)
- Postpartum readmission(After delivery before 6 weeks postpartum)
- Maternal mortality(Form conception till 6 weeks partum.)
- Late abortion(After 20 weeks till 28 weeks GA)
- Change in maternal hemoglobin(Anytime during pregnancy)
- Transfer to a higher level of care(Anytime during pregnancy and postpartum till 6 weeks)
- Perinatal mortality(From 28 weeks GA till 1 weeks post partum)
- Birth weight less than 2500g and less than 1500g
- Fetal loss or Spontaneous abortion
- Still birth(at delivery)
- Medical termination of pregnancy
研究者
Dr Mrityunjay Metgud
Jawaharlal Nehru Medical College