Understanding postpartum pulmonary artery pressure in women with preeclampsia and antiphospholipid syndrome
Official title: Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.
Run by Insel Gruppe AG, University Hospital Bern · NCT05679206 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 16 Years and up |
| Sex | Women only |
| Enrollment | 900 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | December 20, 2022 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | May 9, 2024 |
| Trial ID | NCT05679206 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women over 16 years old who have suffered from preeclampsia during pregnancy.
✕Probably not a fit
Patients under 16 years old or those with incomplete or ambiguous data regarding their eligibility will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pre-eclampsia risk in pregnancies after oocyte donation
We will follow pregnant women who used donated eggs and women who used their own eggs to see if pregnancies after oocyte donation lead to a higher risk of pre-eclampsia.
-
Use of metformin to prolong pregnancy in preterm preeclampsia in the Netherlands
In pregnant people with preterm preeclampsia, this study tests whether metformin can help them stay pregnant longer compared with placebo.
-
Remote monitoring and education for postpartum blood pressure management
This study is testing if a program that combines remote blood pressure monitoring and education with daily text reminders can help new moms manage high blood pressure after giving birth.
-
Levosimendan to see if it helps the heart after PEA in CTEPH
This small randomized trial tests whether giving levosimendan around surgery helps reduce pulmonary artery pressure and support right heart function after pulmonary endarterectomy for CTEPH.
-
Early treatment with inhaled treprostinil for exercise-induced pulmonary hypertension in ILD or CTD
This study tests whether inhaled treprostinil added to standard care can improve exercise-related lung blood flow and function in adults with ILD or CTD who develop pulmonary hypertension during exercise.
-
Brazilian Portuguese version of EmPHasis-10 for pulmonary hypertension
This study tests a Brazilian Portuguese version of the EmPHasis-10 questionnaire to see if it reliably measures quality of life in adults with pulmonary hypertension in Porto Alegre, Brazil.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.