Early Detection and Management for Postpartum Pre-eclampsia
(PREDiCT-NPL Trial)
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Biomarker Evaluation
Participants undergo biomarker evaluation with sFlt-1/PlGF ratio testing before delivery to assess risk for postpartum preeclampsia
Treatment
High-risk participants are randomized to early detection and management of postpartum preeclampsia with remote blood pressure monitoring, education, and antihypertensive medication
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on hypertension-related healthcare utilization and morbidity
What Are the Treatments Tested in This Trial?
Interventions
- Early detection and management of postpartum preeclampsia bundle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Dhulikhel Hospital
Collaborator