Pre-Eclampsia; Complicating PregnancyNCT05679206
Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure
An observational study of Pre-Eclampsia; Complicating Pregnancy and Antiphospholipid Syndrome in Pregnancy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
- What is being tested?
- Echocardiography images and 24-hour ambulatory blood pressure monitoring
- How many people
- 900 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern, 3010
Emrush Rexhaj, MD, +41316322111, emrush.rexhaj@insel.ch
Theo Meister, MD, +41316321890, theo.meister@insel.ch
About this study
Official title: Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.
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.
Read the detailed description
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.
- Conditions
- Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
- Being tested
- Echocardiography images, 24-hour ambulatory blood pressure monitoring
- Keywords
- Pre-Eclampsia, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography imagesDiagnostic test
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
24-hour ambulatory blood pressure monitoringDiagnostic test
Twenty-four-hour ABPM performed between three months and three years after delivery using validated recorders (Spacelabs model 90217, USA)
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia and obstetric Antiphospholipid Syndrome | Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected. Receives: Diagnostic Test: Echocardiography images; Diagnostic Test: 24-hour ambulatory blood pressure monitoring | |
| Preeclampsia without obstetric Antiphospholipid Syndrome | Women in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected. Receives: Diagnostic Test: Echocardiography images; Diagnostic Test: 24-hour ambulatory blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic pulmonary artery pressure
Right ventricle to right atrium (RV/RA) gradient will be mesured using echocardiography
Measured: three months and three years after delivery
Secondary outcomes (1)
Changes in systemic arterial blood pressure
Twenty-four-hour ambulatory blood pressure monitoring
Measured: three months and three years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Dec 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pre-Eclampsia; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrush Rexhaj, Insel Gruppe AG, University Hospital Bern
- Investigators
- Emrush Rexhaj, MD, Principal investigator, Insel Gruppe AG, Inselspital, Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679206
- Sponsor's protocol ID
- 2022-01957
- Status last verified
- May 2024
- First submitted
- 21 Dec 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benschop L, Duvekot JJ, Roeters van Lennep JE. Future risk of cardiovascular disease risk factors and events in women after a hypertensive disorder of pregnancy. Heart. 2019 Aug;105(16):1273-1278. doi: 10.1136/heartjnl-2018-313453. Epub 2019 Jun 7.
PubMed 31175138Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). The hypertensive disorders of pregnancy: ISSHP classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2018 Jul;13:291-310. doi: 10.1016/j.preghy.2018.05.004. Epub 2018 May 24. No abstract available.
PubMed 29803330Heilmann L, Schorsch M, Hahn T, Fareed J. Antiphospholipid syndrome and pre-eclampsia. Semin Thromb Hemost. 2011 Mar;37(2):141-5. doi: 10.1055/s-0030-1270341. Epub 2011 Mar 2.
PubMed 21370215Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.
PubMed 31727424Leon LJ, McCarthy FP, Direk K, Gonzalez-Izquierdo A, Prieto-Merino D, Casas JP, Chappell L. Preeclampsia and Cardiovascular Disease in a Large UK Pregnancy Cohort of Linked Electronic Health Records: A CALIBER Study. Circulation. 2019 Sep 24;140(13):1050-1060. doi: 10.1161/CIRCULATIONAHA.118.038080. Epub 2019 Sep 23.
PubMed 31545680Olie V, Moutengou E, Grave C, Deneux-Tharaux C, Regnault N, Kretz S, Gabet A, Mounier-Vehier C, Tsatsaris V, Plu-Bureau G, Blacher J. Prevalence of hypertensive disorders during pregnancy in France (2010-2018): The Nationwide CONCEPTION Study. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1344-1353. doi: 10.1111/jch.14254. Epub 2021 May 27.
PubMed 34042277Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.
PubMed 30920918
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.
- ClinicalTrials.gov ID
- NCT05679206
- Acronym / sponsor ID
- 2022-01957
- Conditions
- Pre-Eclampsia; Complicating Pregnancy, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
- Keywords
- Pre-Eclampsia, Antiphospholipid Syndrome in Pregnancy, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia and obstetric Antiphospholipid Syndrome | – | Diagnostic Test: Echocardiography images, Diagnostic Test: 24-hour ambulatory blood pressure monitoringWomen in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected. |
| Preeclampsia without obstetric Antiphospholipid Syndrome | – | Diagnostic Test: Echocardiography images, Diagnostic Test: 24-hour ambulatory blood pressure monitoringWomen in this group wil be followed during 3 years. Echocardiography images, 24-hour ambulatory blood pressure monitoring will be collected. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- Age: > 16 years.
- Consent or waiver of consent according Chapter 9
- Preeclampsia
- New onset hypertension (blood pressure >140/90mmHg on multiple occasions after 20 weeks of gestation)
- Proteinuria (urine protein >300mg /24h or 2+ or higher in dipstick on multiple occasions)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography imagesTransthoracic 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 | Diagnostic test | Preeclampsia and obstetric Antiphospholipid Syndrome, Preeclampsia without obstetric Antiphospholipid Syndrome |
| 24-hour ambulatory blood pressure monitoringTwenty-four-hour ABPM performed between three months and three years after delivery using validated recorders (Spacelabs model 90217, USA) | Diagnostic test | Preeclampsia and obstetric Antiphospholipid Syndrome, Preeclampsia without obstetric Antiphospholipid Syndrome |
Primary outcome
Changes in systolic pulmonary artery pressure
Time frame: three months and three years after delivery
Right ventricle to right atrium (RV/RA) gradient will be mesured using echocardiography
1 secondary outcome
Changes in systemic arterial blood pressure
Time frame: three months and three years after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 31175138Benschop L, Duvekot JJ, Roeters van Lennep JE. Future risk of cardiovascular disease risk factors and events in women after a hypertensive disorder of pregnancy. Heart. 2019 Aug;105(16):1273-1278. doi: 10.1136/heartjnl-2018-313453. Epub 2019 Jun 7.
- Background: PubMed 29803330Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, Hall DR, Warren CE, Adoyi G, Ishaku S; International Society for the Study of Hypertension in Pregnancy (ISSHP). The hypertensive disorders of pregnancy: ISSHP classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2018 Jul;13:291-310. doi: 10.1016/j.preghy.2018.05.004. Epub 2018 May 24. No abstract available.
- Background: PubMed 21370215Heilmann L, Schorsch M, Hahn T, Fareed J. Antiphospholipid syndrome and pre-eclampsia. Semin Thromb Hemost. 2011 Mar;37(2):141-5. doi: 10.1055/s-0030-1270341. Epub 2011 Mar 2.
- Background: PubMed 31727424Honigberg MC, Zekavat SM, Aragam K, Klarin D, Bhatt DL, Scott NS, Peloso GM, Natarajan P. Long-Term Cardiovascular Risk in Women With Hypertension During Pregnancy. J Am Coll Cardiol. 2019 Dec 3;74(22):2743-2754. doi: 10.1016/j.jacc.2019.09.052. Epub 2019 Nov 11.
- Background: PubMed 31545680Leon LJ, McCarthy FP, Direk K, Gonzalez-Izquierdo A, Prieto-Merino D, Casas JP, Chappell L. Preeclampsia and Cardiovascular Disease in a Large UK Pregnancy Cohort of Linked Electronic Health Records: A CALIBER Study. Circulation. 2019 Sep 24;140(13):1050-1060. doi: 10.1161/CIRCULATIONAHA.118.038080. Epub 2019 Sep 23.
- Background: PubMed 34042277Olie V, Moutengou E, Grave C, Deneux-Tharaux C, Regnault N, Kretz S, Gabet A, Mounier-Vehier C, Tsatsaris V, Plu-Bureau G, Blacher J. Prevalence of hypertensive disorders during pregnancy in France (2010-2018): The Nationwide CONCEPTION Study. J Clin Hypertens (Greenwich). 2021 Jul;23(7):1344-1353. doi: 10.1111/jch.14254. Epub 2021 May 27.
- Background: PubMed 30920918Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emrush Rexhaj, MD principal investigator
Insel Gruppe AG, Inselspital, Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia; Complicating Pregnancy and Antiphospholipid Syndrome in Pregnancy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emrush Rexhaj, MD (+41 31 632 21 11, emrush.rexhaj@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in systolic pulmonary artery pressure (time frame: three months and three years after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679206, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.