Health Trials

Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study

ConditionPostpartum Preeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early detection and management of postpartum preeclampsia bundle

    Other intervention

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: High-risk InterventionExperimental treatment 1 intervention
Group B: High-Risk ControlNo intervention 0 interventions
Group C: Low-risk ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Study feasibility

Assess study feasibility as measured by retention rate.

Time frame
1 year

Secondary outcomes

1

Composite outcome of hypertension-related healthcare utilization and morbidity.

Assess the effect of early monitoring and management of postpartum preeclampsia on the incidence of a composite outcome including hypertension requiring in-person medical evaluation and hypertension-related morbidity.

Time frame
4 weeks postpartum
2

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

Assess the sFlt-1/PlGF ratio predictive ability of de novo postpartum preeclampsia in antenatally normotensive patients.

Time frame
2 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Dhulikhel Hospital

Collaborator

Source ClinicalTrials.gov
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