NCT05155852

Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women with Postpartum Hypertension

NIRS-Based Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women with Postpartum Hypertension

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.

Detailed description

Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM. Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women. This is a single center feasibility study that will include up to 10 women. Postpartum women admitted to the obstetrics high-risk stepdown unit for management of postpartum hypertension will be eligible for this study. Informed consent will be obtained from participants prior to enrollment in the study.

Conditions

• Preeclampsia
• Hypertension in Pregnancy

Timeline

• Start date: 2021-08-13
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2021-12-14
• Last updated: 2024-09-23

Locations

1 site across 1 country: United States