Understanding postpartum pulmonary artery pressure in women with preeclampsia and antiphospholipid syndrome
Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.
This study looks at the heart health of women who had high blood pressure during pregnancy and also have a specific blood condition, to see how these issues affect them after childbirth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05679206 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate postpartum pulmonary artery pressure in women who experienced preeclampsia during pregnancy, particularly focusing on those with antiphospholipid syndrome. Participants will be monitored for up to three years after childbirth to assess the long-term cardiovascular effects of these conditions. The study involves clinical examinations, echocardiography, blood sampling, and 24-hour ambulatory blood pressure monitoring to gather comprehensive data on the participants' health. This research represents a unique cohort in Switzerland, providing valuable insights into the intersection of these serious pregnancy complications and their long-term impacts.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 16 years old who have suffered from preeclampsia during pregnancy.
Not a fit: Patients under 16 years old or those with incomplete or ambiguous data regarding their eligibility will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of cardiovascular risks in women who have experienced preeclampsia and antiphospholipid syndrome.
How similar studies have performed: While this specific approach is novel in Switzerland, similar studies have indicated the importance of monitoring cardiovascular health in women with a history of preeclampsia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Emrush Rexhaj, MD — Insel Gruppe AG, Inselspital, Bern
- Study coordinator: Emrush Rexhaj, MD
- Email: emrush.rexhaj@insel.ch
- Phone: +41 31 632 21 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.