RecruitingNot Applicable

Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

Switzerland900 participantsStarted 2022-12-20

Plain-language summary

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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in systolic pulmonary artery pressure

Timeframe: three months and three years after delivery

Trial details

NCT IDNCT05679206

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Emrush Rexhaj, MD

+41 31 632 21 11 emrush.rexhaj@insel.ch

View on ClinicalTrials.gov More Pre-Eclampsia; Complicating Pregnancy trials