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Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

ConditionsPre-Eclampsia; Complicating PregnancyAntiphospholipid Syndrome in PregnancyPulmonary Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: > 16 years.

Consent or waiver of consent according Chapter 9

Preeclampsia

Proteinuria (urine protein >300mg /24h or 2+ or higher in dipstick on multiple occasions)

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiography images

    Diagnostic 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 monitoring

    Diagnostic test

    Twenty-four-hour ABPM performed between three months and three years after delivery using validated recorders (Spacelabs model 90217, USA)

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Preeclampsia and obstetric Antiphospholipid Syndrome2 interventions
Group B: Preeclampsia without obstetric Antiphospholipid Syndrome2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Changes in systemic arterial blood pressure

Twenty-four-hour ambulatory blood pressure monitoring

Time frame
three months and three years after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov
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