NCT05679206Recruiting
Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure
Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 21 Dec 2022
- Start date
- 20 Dec 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- NCT number
- NCT05679206
What you commit to
- Study type: Observational
- Planned participants: 900
- From 20 Dec 2022 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age: \< 16 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.