Early Detection and Management for Postpartum Pre-eclampsia

(PREDiCT-NPL Trial)

Not yet recruiting at 1 trial location

Overseen By Alyssa Hernandez, DO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Nifedipine

Disqualifiers: Hypertension, Preeclampsia, Eclampsia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks postpartum

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to detect and manage preeclampsia, a condition with high blood pressure that occurs after childbirth. Researchers will test whether certain blood markers can predict who is at risk and then explore different care strategies for high-risk patients. Individuals who have had preeclampsia before or have conditions like diabetes or kidney disease, and plan to deliver at Dhulikhel Hospital, might be suitable for this study.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance care for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this early detection and management protocol is safe for postpartum preeclampsia?

Research has shown that checking blood pressure from home after childbirth is safe and effective. Studies suggest that using technology for blood pressure monitoring helps detect problems early and can be as reliable as traditional follow-up visits. For example, both patients and doctors can notice changes in blood pressure more quickly, allowing for faster treatment of any issues.

The treatment plan includes nifedipine ER, a common medication used to control high blood pressure. Many patients tolerate this medication well, and it is often used safely for other high blood pressure-related conditions.

Overall, strong evidence supports the safety of this approach. Both remote monitoring and nifedipine ER have shown positive results in previous studies, suggesting that the treatment plan is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on early detection and management of postpartum pre-eclampsia, a condition that can be challenging to manage after childbirth. Unlike standard care, which often involves monitoring and treating symptoms as they arise, this approach uses a proactive strategy by identifying high-risk individuals through the sFlt-1/PlGF ratio. This allows for early intervention with remote blood pressure monitoring and education, alongside the administration of nifedipine ER for outpatient care. The trial aims to prevent complications by managing mild hypertension before symptoms become severe, potentially improving outcomes for new mothers.

What evidence suggests that this trial's early detection and management strategies could be effective for postpartum preeclampsia?

This trial will compare different approaches for managing postpartum preeclampsia. Research has shown that checking blood pressure at home after giving birth is a reliable and effective way to manage high blood pressure. Participants in the "High-risk Intervention" arm will receive early detection and management of postpartum preeclampsia through remote blood pressure monitoring, education, and antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild-range blood pressure. Studies have found that home blood pressure monitoring can help catch problems early and improve care. This is especially important for women who had high blood pressure during pregnancy, as it helps identify issues that might continue or worsen after delivery. Additionally, taking blood pressure medication, like nifedipine ER, is part of treating mild high blood pressure and has been proven to help manage blood pressure levels. This approach aims to catch and manage postpartum preeclampsia early, potentially reducing serious health risks. ^{1 6 7 8 9}

Who Is on the Research Team?

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for individuals at risk of developing high blood pressure or preeclampsia after childbirth. Participants will be tested using biomarkers before delivery to predict the likelihood of postpartum preeclampsia.

Inclusion Criteria

Admitted for labor at Dhulikhel Hospital, or intend to deliver at Dhulikhel Hospital

At risk for preeclampsia, using the Clinical Risk Assessment for Preeclampsia according to ACOG and USPSTF:

I am at least 36 weeks pregnant with no major fetal issues.

Exclusion Criteria

Antenatal hypertensive disorder of pregnancy diagnosis, including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines

Chronic hypertension, according to ACOG guidelines

Inability or unwillingness to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Evaluation

Participants undergo biomarker evaluation with sFlt-1/PlGF ratio testing before delivery to assess risk for postpartum preeclampsia

1 week

Treatment

High-risk participants are randomized to early detection and management of postpartum preeclampsia with remote blood pressure monitoring, education, and antihypertensive medication

4 weeks postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on hypertension-related healthcare utilization and morbidity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Early detection and management of postpartum preeclampsia bundle

Trial Overview The study tests a 'bundle' of care strategies focused on early detection and management of postpartum preeclampsia in Nepal, using sFlt-1/PlGF ratio testing to identify those at high risk.

How Is the Trial Designed?

Group I: High-risk Intervention Experimental Treatment 1 Intervention

Participants with high-risk sFlt-1/PlGF ratio randomized to early detection and management of postpartum preeclampsia with remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.

Group II: High-Risk Control Active Control 1 Intervention

Participants with high-risk sFlt-1/PlGF ratio randomized to standard postpartum care.

Group III: Low-risk Control Active Control 1 Intervention

Participants with low-risk sFlt-1/PlGF ratio will not be randomized, but will remain enrolled to assess the exploratory outcome of biomarker predictive ability.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Dhulikhel Hospital

Collaborator

Trials

8

Recruited

4,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10407242/

Postpartum remote home blood pressure monitoring Remote monitoring of postpartum hypertensive disorders of pregnancy is a reliable and effective alternative to current follow-up care models.

2. ajogmfm.org ajogmfm.org/article/S2589-9333(25)00235-6/fulltext

Postpartum Health-Care Utilization and Blood Pressure ... This is a retrospective cohort study of postpartum individuals diagnosed with hypertension in pregnancy, including pre-pregnancy hypertension, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589933325002356

Postpartum Health-Care Utilization and Blood Pressure ... This is a retrospective cohort study of postpartum individuals diagnosed with hypertension in pregnancy, including pre-pregnancy hypertension, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03185455

Remote Surveillance of Postpartum Hypertension Women with hypertensive disorders of pregnancy need postpartum blood pressure (BP) surveillance to detect persistent hypertension.

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum This review provides insights into the physiologic and pathophysiologic hemodynamic alterations that affect BP during pregnancy and the ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.034031

Implementation of a Cell‐Enabled Remote Blood Pressure ... A cell‐enabled postpartum remote BP monitoring program was successful in uniformly monitoring BP and capturing hypertension among a diverse, safety‐net ...

7. escholarship.org escholarship.org/content/qt8m98k920/qt8m98k920_noSplash_40e12bdb631beb4221a8dd516197700d.pdf

Remote Patient Monitoring (RPM) For Postpartum ... RPM allowed participants and their providers to monitor blood pressures more closely, resulting in earlier detection and treatment of concerning results.

8. saferbirth.org saferbirth.org/psbs/severe-hypertension-in-pregnancy/

Severe Hypertension In Pregnancy | AIM The bundle provides actionable steps that can be adapted to a variety of facilities and resource levels to improve quality of care and outcomes.

9. heartsafemotherhood.org heartsafemotherhood.org/sites/default/files/Association%20of%20a%20Remote%20Blood%20Pressure%20Monitoring%20Program%20With%20Postpartum%20Adverse%20Outcomes.pdf

Association of a Remote Blood Pressure Monitoring ... The purpose of the current study was to evaluate the association of a text-message based remote blood pressure monitoring program with adverse ...