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NCT05679206
Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure
Conditions: Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
Sex: Female
Ages: 16 Years – N/A
Enrollment: 900
Sponsor: University Hospital Inselspital, Berne
Location: Switzerland
Summary
The primary goal of this observational study is to learn about postpartum pulmonary artery pressure in women who suffered from Preeclampsia and Antiphospholipid Syndrome.The main question it aims to answer is whether the conjunction of preeclampsia with obstetric antiphospholipid syndrome significantly foster the development of long-lasting pulmonary hypertension.Only participants who suffered from preeclampsia during pregnancy will be followed for a period up to 3 years postpartum.
Researchers will compare women with or without obstetric antiphospholipid syndrome.
Eligibility Criteria
Inclusion Criteria:Age: > 16 years.Consent or waiver of consent according Chapter 9PreeclampsiaDefined as:• New onset hypertension (blood pressure >140/90mmHg on multiple occasions after 20 weeks of gestation)In combination with new onset of 1 or more of the following:Proteinuria (urine protein >300mg /24h or 2+ or higher in dipstick on multiple occasions)Platelet count <100,000/microL,Serum creatinine >97.2 micromol/L,Liver transaminases at least twice the upper limit of the normal concentrations,Pulmonary edema,New-onset and persistent headache,Visual symptoms.
-Postnatal follow up at the obstetrical and cardiology clinic, Inselspital Bern, Switzerland.Exclusion Criteria:Age: < 16 yearsIncomplete or ambiguous data: if data confirming the eligibility criteria or data to analyze the primary endpoint is not fully available or despite efforts assessed as significantly ambiguous, the data set will be excluded from analyses, since no analysis is possible
Source: ClinicalTrials.gov (NCT05679206). StuddyBuddy aggregates publicly available trial information.