Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study

NCT07185204 | Not Yet Recruiting

• 1 other identifier: PRO00056073
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Postpartum Preeclampsia

Keywords

Preeclampsia; Hypertension; Pregnancy; Postpartum

Outcome Measures

Primary Outcomes (1)

• Study feasibility

  Assess study feasibility as measured by retention rate.

  1 year

Secondary Outcomes (2)

• Composite outcome of hypertension-related healthcare utilization and morbidity.

  4 weeks postpartum

• Predictive ability of sFlt-1/PlGF ratio for de novo postpartum preeclampsia

  2 weeks postpartum

Study Arms (3)

High-risk Intervention

EXPERIMENTAL

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.

Other: Early detection and management of postpartum preeclampsia bundle

High-Risk Control

NO INTERVENTION

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

Low-risk Control

NO 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.

Interventions

Early detection and management of postpartum preeclampsia bundle OTHER

Remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.

High-risk Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or more high risk factors:
• History of preeclampsia
• Type 1 or 2 diabetes
• Multifetal gestation?
• Renal disease
• Autoimmune disease
• or more moderate risk factors:
• Nulliparity
• BMI \> 30
• First-degree relative with a history of preeclampsia
• African American race

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Dhulikhel Hospital: collaborator

Study Sites (2)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Dhulikhel Hospital

Dhulikhel, Nepal

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Palatnik, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Hernandez, DO

CONTACT

4148055285; alyhernandez@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: September 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NE (1)