Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure
Recruiting now
Conditions studied: Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
In brief
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.
Key facts
- Study ID
- NCT05679206
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 900
- Starts
- 2022-12-20
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2024-05-09
Who can join
Age: 16 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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