Preeclampsia Associated Vascular Aging

NCT04484766 | Unknown

• 1 other identifier: 2019-1498
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate cardiovascular health, especially endothelial health, of women after pre-eclampsia compared to women without pre-eclampsia, and to compare women who had taken PETN during pregnancy with women who had not attempted treatment

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (3)

• vascular health as combined outcome

  Comparison of the vascular health of patients after pre-eclampsia with that of women with complication-free pregnancies 10-20 years after pregnancy by assessing physical parameters (height, weight, Blood pressure, bioelectric impedance analysis), measuring cardiac output, transthoracic echocardiography, carotid intima media thickness, total vascular resistance, flow mediated dilation, critical flicker frequency, puls-wave velocity and augmentation index

  1 day 10-20 years after pregnancy

• Potential long-term effect of PETN treatment using combined outcome of vascular health measurements in correlaation with treatment with PETN

  Analysis of a possible long-term effect of PETN treatment during pregnancy based on a vascular health comparison of patients who received PETN in the PETN pilot study from 2002 to 2008, or who received it in a personalised therapy trial, with those who received placebo or no therapy

  1 day 10-20 years after pregnancy

• Endothelial cell senescence using senescence characterization of young and treated HUVEC cells

  In vitro analysis of endothelial cell senescence established by hosting group after pre-eclampsia induced stress effect, as well as the possible protective effect of PETN on endothelial cell aging

  1 day 10-20 years after pregnancy

Study Arms (2)

Patient after pre-eclampsia

Patients with pre-eclampsia who were treated at the University Hospital of Jena between 1999-2009.

Other: Primary data collection

Patients after PETN treatment

Patients of the PETN pilot study, with PETN and patients who received PETN as an individual therapy trial

Other: Primary data collection

Interventions

Primary data collection OTHER

Primary data collection takes place via questionnaires outside the study centre. All other investigations take place at the study centre: * Physical examination: height, weight, BMI, blood pressure * Cardiac examination: cardiac output * Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index * Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel)

Also known as: Physical examination, Cardiac measurement, Vascular Measurement, Serum analysis

Patient after pre-eclampsia; Patients after PETN treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pre-eclampsia 10 to 20 years ago. The patients are matched with the next consenting patient who gave birth without pregnancy complications. Only singleton pregnancies born between the 24th and 42nd week of pregnancy are considered. Patients with and without PETN treatment are recruited from the patients who participated in the PETN pilot study from 2002 to 2008. In addition, patients are recruited who received PETN treatment as a personalised therapy trial. These are matched by patients without treatment. The matching includes the indication for treatment, the week of pregnancy at diagnosis and the percentiles of fetal growth

You may qualify if:

• Participants of the PETN pilot study from 2002-2008
• controls: uneventful pregnancies from 2002-2008
• Patients with pre-eclampsia with PETN treatment 10-20 years ago
• Controls: patients with pre-eclampsia without PETN treatment 10-20 years ago
• Written Informed Consent
• Singleton pregnancy

You may not qualify if:

• Patients who refuse to participate in the study
• Impossibility of the outpatient presentation

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Anna Multhaup, Dr. med.

  Klinik für Geburtsmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: July 24, 2020
• Study Start: September 1, 2019
• Primary Completion: December 10, 2021
• Study Completion: June 30, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)