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Search / Trial NCT05679206

Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 9, 2023

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Pre Eclampsia Antiphospholipid Syndrome In Pregnancy Pulmonary Hypertension

ClinConnect Summary

This clinical trial is studying how certain pregnancy complications, specifically preeclampsia and antiphospholipid syndrome, may affect lung pressure after childbirth. The main goal is to find out if these conditions together increase the risk of developing long-lasting pulmonary hypertension, which is high blood pressure in the lungs. Researchers will observe women who had preeclampsia during their pregnancies for up to three years after giving birth, comparing those with and without antiphospholid syndrome.

To be eligible for this study, participants must be women over the age of 16 who experienced preeclampsia during pregnancy. Preeclampsia is characterized by high blood pressure and other symptoms that can occur after the 20th week of pregnancy. Those who join the study can expect regular follow-ups at a specialized clinic in Switzerland, where their health will be monitored to gather important information about their lung pressure and overall well-being after having a baby. The trial is currently looking for participants, and being part of this study could help improve understanding of how these conditions impact women's health postpartum.

Gender

FEMALE

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

About Insel Gruppe Ag, University Hospital Bern

Insel Gruppe AG, the umbrella organization for the University Hospital Bern, is a leading healthcare provider in Switzerland, renowned for its commitment to advancing medical research and patient care. As a key player in clinical trials, Insel Gruppe AG integrates cutting-edge scientific inquiry with clinical excellence, facilitating innovative studies that span a wide range of medical disciplines. The institution prioritizes collaboration with academic partners and industry stakeholders to enhance the understanding of diseases and develop effective treatment options, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Bern, , Switzerland

Patients applied

0 patients applied

Trial Officials

Emrush Rexhaj, MD

Principal Investigator

Insel Gruppe AG, Inselspital, Bern

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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