Personalized Blood Pressure Management for Postpartum Preeclampsia

(PROMIS Trial)

Overseen By Noora Haghighi

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Blood pressure medications

Disqualifiers: Stroke, Seizures, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (NIRS) monitoring for 24 hours. The interventional group will have personalized blood pressure targets according to results of NIRS monitoring which will be updated in real time.

Research Team

Eliza Miller, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for women aged 18 or older who are within 6 weeks postpartum after a pregnancy of at least 20 weeks and have been admitted for preeclampsia treatment. Eligible participants must have high blood pressure readings or severe headaches not relieved by over-the-counter meds. Women with recent brain injuries, strokes, seizures, certain neurological diseases, eclamptic seizures, or Reynaud's syndrome cannot participate.

Inclusion Criteria

I am hospitalized for severe preeclampsia with high blood pressure or persistent headaches.

Exclusion Criteria

I understand and can consent to the study.

I have had a stroke, seizures, brain injury, brain surgery, encephalitis, or a demyelinating brain disease.

I have had a recent brain bleed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo continuous non-invasive blood pressure and NIRS monitoring for 24 hours. The interventional group receives personalized blood pressure targets.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NIRS-based personalized blood pressure management

Trial Overview The study tests a new method to manage blood pressure in women with postpartum preeclampsia using standard medications alongside NIRS monitoring. Participants will be split into two groups: one receiving personalized blood pressure targets based on real-time NIRS data and the other undergoing regular care without personalized targets.

Participant Groups

Group I: Interventional Experimental Treatment 1 Intervention

Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.

Group II: Observational Cohort Active Control 1 Intervention

Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+