Status:
NOT_YET_RECRUITING
Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Dhulikhel Hospital
Conditions:
Postpartum Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07185204
Start Date
October 1 2025
End Date
June 1 2026
Last Update
September 22 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
2
Dhulikhel Hospital
Dhulikhel, Nepal