Preeclampsia Clinical Trials

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Postpartum Preeclampsia Early Detection and Treatment: Using Biomarkers to Implement Risk-stratified Intervention (Nepal Pilot Randomized Controlled Trial)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

∙ BMI \> 30

∙ 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

Locations
United States
Wisconsin
Medical College of Wisconsin
ACTIVE_NOT_RECRUITING
Milwaukee
Other Locations
Nepal
Dhulikhel Hospital
RECRUITING
Dhulikhel
Contact Information
Primary
Alyssa Hernandez, DO
alyhernandez@mcw.edu
4148055285
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 60
Treatments
Experimental: High-risk 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.
No_intervention: High-Risk Control
Participants with high-risk sFlt-1/PlGF ratio randomized to standard postpartum care.
No_intervention: Low-risk Control
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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin
Collaborators: Dhulikhel Hospital

This content was sourced from clinicaltrials.gov