Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study (PREDiCT-NPL)

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Postpartum Preeclampsia

Treatments: Other: Early detection and management of postpartum preeclampsia bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT07185204

PRO00056073

Details and patient eligibility

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. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

High-risk Intervention

Experimental group

Description:

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.

Treatment:

Other: Early detection and management of postpartum preeclampsia bundle

High-Risk Control

No Intervention group

Description:

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

Low-risk Control

No Intervention group

Description:

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.