Status:
RECRUITING
Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Pre-Eclampsia; Complicating Pregnancy
Antiphospholipid Syndrome in Pregnancy
Eligibility:
FEMALE
16+ years
Brief 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...
Detailed Description
Preeclampsia (PE), a multisystem disease affecting 2-8% of all pregnancies is a major cause of mother and child mortality and morbidity worldwide. On the long term, women who suffered from PE during p...
Eligibility Criteria
Inclusion Criteria:
- Age: > 16 years.
- Consent or waiver of consent according Chapter 9
- Preeclampsia
Defined 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 years
- Incomplete 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
Key Trial Info
Start Date :
December 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT05679206
Start Date
December 20 2022
End Date
December 31 2028
Last Update
May 9 2024
Active Locations (1)
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1
Inselspital
Bern, Switzerland, 3010