NCT07185204 · Medical College of Wisconsin
Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study
(PREDiCT-NPL)
What this study is about
The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia.
View original scientific description
The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.
Interventions
OTHER
Early detection and management of postpartum preeclampsia bundle
Remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.
Primary outcome measures
Study feasibility
Time frame: 1 year
Assess study feasibility as measured by retention rate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pregnant patients ≥ 36 weeks gestation without major fetal anomalies
- Age ≥ 18 years
- 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
- 1 or more high risk factors:
- History of preeclampsia
- Type 1 or 2 diabetes
- Multifetal gestation?
- Renal disease
- Autoimmune disease
- 2 or more moderate risk factors:
- Nulliparity
- First-degree relative with a history of preeclampsia
- African American race
- Low socioeconomic status
- Age \> 35 years
- History of low birthweight or small for gestational age
- Previous adverse pregnancy outcome
- Interpregnancy interval \> 10 years
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
- Known allergy or contraindication to nifedipine
- Inability or unwillingness to provide informed consent
- Two or more blood pressures with an SBP ≥140 or DBP ≥90 after consent and prior to sFlt-1/PlGF testing (screen failure criteria)
Where
- Milwaukee, Wisconsin
Collaborators
Dhulikhel Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations