Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study (NCT07185204) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study
United States, Nepal60 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.