Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study
Recruiting · NCT07185204 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Early detection and management of postpartum preeclampsia bundle
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
2 locations listed across 1 US state.
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Dhulikhel Hospital - Dhulikhel, Nepal