RecruitingNCT05679206

Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure

Association Between Preeclampsia, Antiphospholipid Syndrome and Postpartum Pulmonary Artery Pressure, Systemic Arterial Pressure and Cardiovascular Function.

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

900 participants

Start Date

Dec 20, 2022

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension Pre-Eclampsia; Complicating Pregnancy Antiphospholipid Syndrome in Pregnancy

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.

Eligibility

Sex: FEMALEMin Age: 16 Years

Inclusion Criteria13

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 Criteria2

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

Interventions

DIAGNOSTIC_TESTEchocardiography images

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

DIAGNOSTIC_TEST24-hour ambulatory blood pressure monitoring

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