Early detection of cardiovascular risk factors after pregnancy complicated by hypertensive disorders or spontaneous preterm birth

Completed

• Conditions: cardiovascular disease after hypertensive disorders in pregnancy or after spontaneous preterm birth; 10019280; 10057166; 10026908

• Registration Number: NL-OMON45089
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 687

Inclusion Criteria

Women with a history of early preeclampsia (<34 weeks gestation) who gave labour in a University Medical Center in the Netherlands between 1998-2005 (preeclampsia cases)
Women with a history of spontaneous preterm birth (<37 weeks gestation) who gave labour in a University Medical Center in the Netherlands between 2001-2008 (SPTB cases)
Women with a history of uncomplicated pregnancy who gave labour after 37 weeks of gestation in a University Medical Center in the Netherlandsbetween 1998-2008 and within 3 months delivery of the case (controls)

Exclusion Criteria

Multiple pregnancy, chronic hypertension, diabetes mellitus before pregnancy or gestational diabetes during the index pregnancy, cardiovascular disease before pregnancy, renal disease, coagulation disorders, history of pregnancy complicated by fetal anomalies.
For SPTB cases also: iatrogenic preterm birth, uterine anomaly, history of conisation of the cervix
For controls exclusion: no pregnancies complicated by vascular complications.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Specific targets to identify women suitable for secondary prevention of<br /><br>cardiovascular disease at a relatively young age.<br /><br><br /><br>Preeclampsia study part:<br /><br>-Vascular dysfunction primary outcome: difference in prevalence of the<br /><br>metabolic syndrome and/or circulating microparticles between cases and controls<br /><br>-Diastolic dysfunction primary outcome: difference in diastolic heart function<br /><br>or heart failure between cases and controls.<br /><br><br /><br>Spontaneous preterm birth study part:<br /><br>-Vascular dysfunction primary outcome: difference in prevalence of hypertension<br /><br>and/or circulating microparticles between cases and controls<br /><br>-Diastolic dysfunction primary outcome: difference in the E*mean, one of the<br /><br>cardiac ultrasound parameters of diastolic heart function, between cases and<br /><br>controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Preeclampsia study part:<br /><br>The secondary outcome measure will be a difference in cardiovascular parameters<br /><br>and differences in metabolic venous blood measurements.<br /><br><br /><br>Spontaneous preterm birth study part:<br /><br>The secondary outcome measure will be a difference in 10-year cardiovascular<br /><br>risk, a difference in the prevalence of metabolic syndrome, and differences in<br /><br>cardiovascular parameters and metabolic venous blood measurements</p><br>