An observational study in Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy and Pulmonary Hypertension, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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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.
Preeclampsia (PE), a multisystem disease affecting 2-8% of all pregnancies is a major cause of mother and child mortality and morbidity worldwide. On the long term, women who suffered from PE during pregnancy are prone to develop various cardiovascular diseases including arterial hypertension, heart failure, aortic stenosis, mitral regurgitation and atrial fibrillation.
In an effort to prevent or early detect any potential cardiovascular complications in this population, the investigators implemented in Inselspital, 6 years ago, a join consultation between cardiologist and obstetrician. Since 2016, a roughly 100 women/year have been followed at this consultation. As part of this follow-up, in addition to a clinical examination, echocardiography, blood sampling and 24h ambulatory blood pressure monitoring were performed. To the best of the investigators knowledge, this represent the first cohort of this kind in Switzerland. Therefore, it offers a unique opportunity to study the effect of PE on the long term cardiovascular phenotype.
Although the majority of PE are of unknown origin a fraction is due to an autoimmune disease, the Antiphospholipid Syndrome (APS). APS is known to triple the risk of developing PE and is found in up to 20% in women with the most severe forms of PE. There are two distinguished entities of APS, one associated with vascular complications (vascular APS) and one associated with adverse pregnancy outcomes (obstetric APS (oAPS)). In the former form, the prevalence of pulmonary hypertension has been reported to be between 2% and 17% (incidence in the general population \~ 1/100'000) but remain unknown in oAPS. This is of prime importance as pulmonary arterial hypertension is a rare disease with elevated mortality and limited treatment availability. Furthermore, for unknown raison, women have up to seven times the risk of men to develop PH. Here, the investigators hypothesize that oAPS could be an unrecognized risk factor for the development of PH in women.
In patients who suffered from PE, epidemiological studies shown that the risk for developing arterial hypertension, stroke or heart failure is 2-4 fold higher. But structured follow-up to better target this population is missing. Our established interdisciplinary consultation offer a unique possibility to better understand the link between PE and cardiovascular outcomes later in life. Therefore, the investigators further aimed in this study, first to assess the prevalence of the above mentioned cardiovascular outcomes, and second, to establish prediction models, for example for the development of arterial hypertension in patient that suffered from PE.
The primary objective of this study is to compare the postpartum pulmonary arterial pressure measured non-invasively by echocardiography in women after PE with or without oAPS by collecting routine data for the analysis.The secondary objective is to compare the right and left cardiac function using echocardiography images and the systemic blood pressure between both groups by collecting routine data for the analysis. Further, the investigators aimed to assess the prevalence of arterial hypertension in this population, 3 years postpartum and establish a prediction model of the development of arterial hypertension by collecting routine data for the analysis.
The investigators are planning a single center retrospective and prospective study where routine data is collected to evaluate the objectives described above. In particular, demographic, biophysical as well as echocardiographic parameters of all the patients whose pregnancies were complicated by preeclampsia, and were or will be referred after delivery to our outpatient clinic will be collected and analyzed. All consenting patients (see chapter 9) followed between 2016 and 2025 will be enrolled. All data will be collected during a period ranging from 2016 to 2028 encompassing the first patient enrolment in 2016 and the end of the 3 years routine follow-up of the last patient enrolled in 2025.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 900 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We will retrospectively and prospectively study a cohort of PE patient followed at our interdisciplinary postpartum consultation. Informed consent was/will be obtained by means of a general consent. Only for the analysis relevant clinical data (i.e. Echocardiography, ABPM and blood sampling results) will be extracted from the patient files and encoded (according Swissethics guideline) for further analysis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Defined as:
In combination with new onset of 1 or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected.
Diagnostic Test: Echocardiography images · Diagnostic Test: 24-hour ambulatory blood pressure monitoring
Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected.
Diagnostic Test: Echocardiography images · Diagnostic Test: 24-hour ambulatory blood pressure monitoring
Transthoracic echocardiographic (Vivid E95) performed in all included patients between three months and three years after delivery. * Left ventricular ejection fraction, * Left ventricular mass index, * Septal and lateral mitral annular E-wave velocity assessed by tissue Doppler, * Tricuspid annular plane systolic excursion, * Left atrial volume index, * Right ventricle to right atrium (RV/RA) gradient
Twenty-four-hour ABPM performed between three months and three years after delivery using validated recorders (Spacelabs model 90217, USA)
Changes in systolic pulmonary artery pressure
Right ventricle to right atrium (RV/RA) gradient will be mesured using echocardiography
Time frame: three months and three years after delivery
Changes in systemic arterial blood pressure
Twenty-four-hour ambulatory blood pressure monitoring
Time frame: three months and three years after delivery
Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Dec 2028, 72 months after the start.
Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 72 months is above that.
Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Insel Gruppe AG, University Hospital Bern →