Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study

NCT ID: NCT07185204

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-06-30

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.

Detailed Description

This is a pilot randomized controlled trial of 60 normotensive, pregnant patients randomized to early monitoring and management for postpartum preeclampsia after biomarker evaluation with sFlt-1/PlGF ratio. After obtaining informed consent, participants will undergo preeclampsia risk assessment using sFlt-1/PlGF ratio testing prior to delivery. Patients with a low risk ratio will receive routine postpartum care. Patients with a high risk ratio will be randomized 1:1 to the intervention bundle focused on early detection and management of postpartum preeclampsia versus routine postpartum care. The intervention bundle will include remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild-range BP. The primary outcome is the feasibility of all study procedures, measured by recruitment, retention, adherence, and acceptability. The secondary outcome is to assess the effect of early monitoring and management of postpartum preeclampsia on the composite outcome of hypertension requiring in-person medical evaluation and hypertension-related morbidity. Finally, the exploratory outcome is the predictive ability of sFlt-1/PlGF ratio of de novo postpartum preeclampsia in antenatally normotensive patients who are at risk for HDP based on ACOG/USPSTF criteria. Data on primary and secondary outcomes will be collected from both randomized groups and the non-randomized group with low-risk sFlt-1/PlGF ratio to determine the predictive capability of the test in the postpartum period.

Conditions

Postpartum Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early detection and management of postpartum preeclampsia bundle

Intervention Type: OTHER

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

High-Risk Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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
• 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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dhulikhel Hospital

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Anna Palatnik, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Palatnik, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Dhulikhel Hospital

Dhulikhel, , Nepal

Countries

United States; Nepal

Central Contacts

Alyssa Hernandez, DO

Role: CONTACT

alyhernandez@mcw.edu

4148055285

Facility Contacts

Anna Palatnik, MD

Role: primary

apalatnik@mcw.edu

414-805-6627

Alyssa Hernandez, DO

Role: backup

alyhernandez@mcw.edu

4148055285

Abha Shrestha, MD

Role: primary

abhaobgy@kusms.edu.np

0977-1-5522981

Other Identifiers

PRO00056073

Identifier Type: -

Identifier Source: org_study_id