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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage blood pressure in women with preeclampsia after childbirth. Preeclampsia causes high blood pressure and can lead to severe headaches that resist regular pain relievers. The trial includes two groups: one follows standard care, while the other uses a personalized approach based on real-time monitoring with NIRS-based technology (near-infrared spectroscopy). Women within six weeks postpartum who have experienced very high blood pressure or severe headaches unresponsive to usual medicines may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative care methods that could enhance postpartum health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, since participants will be treated with standard blood pressure medications, it's possible that adjustments to your current medications might be needed.

What prior data suggests that this NIRS-based personalized blood pressure management is safe for postpartum preeclampsia?

Research shows that using NIRS, a type of monitoring technology, for personalized blood pressure management is under study for safety and effectiveness. Other studies have used this method to monitor changes in brain blood flow, particularly in women after childbirth. This allows doctors to adjust treatments in real-time to better meet individual needs.

While specific data about side effects for this exact approach is not yet available, the method involves continuous and non-invasive monitoring. It does not require surgery or breaking the skin, which usually suggests a lower risk of harm. Additionally, the blood pressure medications used in the trial are standard and already known to be safe.

Since this trial is in an early stage, researchers are still collecting more detailed safety data. However, the use of existing, approved medications and a non-invasive monitoring technique indicates a positive safety profile. If considering participation in this trial, these points may help provide reassurance about the safety of joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NIRS-based personalized blood pressure management for postpartum preeclampsia because it offers a tailored approach to managing blood pressure. Unlike the standard care, which uses fixed blood pressure thresholds, this method uses autoregulation to determine optimal blood pressure levels in real-time. This personalized approach could lead to more precise and effective blood pressure control, potentially improving outcomes for new mothers experiencing preeclampsia.

What evidence suggests that NIRS-based personalized blood pressure management is effective for postpartum preeclampsia?

This trial will compare two approaches for managing blood pressure in postpartum preeclampsia. Research has shown that using near infrared spectroscopy (NIRS) to manage blood pressure can help identify issues with how the brain controls blood flow after childbirth. In the interventional arm of this trial, participants will receive autoregulation-guided blood pressure management using NIRS, enabling doctors to observe how blood pressure affects the brain and adjust treatment immediately. Studies have found that people often experience changes in blood pressure after giving birth, leading to more time spent outside safe levels. By monitoring in real-time, doctors can set personalized blood pressure goals, potentially improving health outcomes. This approach aims to make treatment more precise and effective for women with postpartum preeclampsia. Meanwhile, participants in the observational cohort will receive standard guideline-based care. ^{3 4 6 7 8}

Who Is on the Research Team?

Eliza Miller, MD, MS

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12441783/

Aggregated postpartum cerebral autoregulatory curves in ... We modeled aggregated static autoregulatory curves in the postpartum period in individuals with no hypertension, preeclampsia, and chronic hypertension with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528950/

Dynamic cerebral autoregulation in postpartum individuals ... Our results suggest hyperdynamic DCA with impaired dampening effect in the first week postpartum, regardless of preeclampsia diagnosis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05155852

Bedside Monitoring to Identify Impaired Cerebral ... 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 ...

4. researchgate.net researchgate.net/publication/393519832_Increased_Blood_Pressure_Variability_is_Associated_with_More_Time_Spent_Outside_Personalized_Limits_of_Cerebral_Autoregulation_in_Postpartum_Preeclampsia

Increased Blood Pressure Variability is Associated with ... We investigated whether higher BPV in postpartum patients with preeclampsia correlated with more time spent outside the personalized limits of CA.

5. researchgate.net researchgate.net/publication/394856009_Aggregated_postpartum_cerebral_autoregulatory_curves_in_normotensive_individuals_preeclampsia_with_severe_features_and_superimposed_preeclampsia_with_severe_features

Aggregated postpartum cerebral autoregulatory curves in ... We modeled aggregated static autoregulatory curves in the postpartum period in individuals with no hypertension, preeclampsia, and chronic ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40629211/

Increased Blood Pressure Variability is Associated with ... Conclusions: Higher BPV in postpartum patients with preeclampsia correlated with more time outside the personalized limits of CA. High BPV may ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05155852

Bedside Monitoring to Identify Impaired Cerebral ... The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women.

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.023694

Phenotype‐Directed Management of Hypertension in ... This narrative review discusses the integration of phenotype‐based clinical strategies in the management of high‐risk pregnant patients.