Clinical Monitoring of Endothelial Dysfunction for Pregnant Women and in the Perioperative Course

Claudia Spies

Status: Terminated

Conditions: Endothelial Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT01311297

POPEYE

Details and patient eligibility

About

A single- center prospective observational study. This study evaluates different aspects of endothelial function. It investigates the endothelial leakage with the venous occlusion plethysmography and the flow-mediated vasodilatation by ischaemia reperfusion testing.

Enrollment: 47 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Offered patient information and written informed consent

• Female patients aged greater than or equal to 18 years:

  1. for reduction of a primary ovarian tumour or recidive of an ovarian tumour

  2. pregnant patients with:

     • clinical normal pregnancy
     • pregnancy with weight gain of more than 10 kg
     • pregnancy and gestosis

  3. healthy volunteers

Exclusion criteria

• Persons without the capacity to consent
• Unability of German language use
• Lacking willingness to save and hand out data within the study
• Accommodation in an institution due to an official or judicial order
• (Unclear) history of alcohol or substances disabuse
• Coworker of the Charité
• Advanced disease of the oesophagus or upper respiratory tract
• Operation in the area of the oesophagus or nasopharynx within the last two months
• Neurological or psychiatric disease
• CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospital stay
• American Society of Anaesthesiologists (ASA) classification greater than IV
• Renal insufficiency (dependency of haemodialysis)
• Pulmonal oedema in thorax x-ray
• History of intracranial hemorrhage within one year of participation in the study
• Conditions following venous thrombosis within the last three years before study inclusion
• Inflammatory or reflective disease of blood vessels (Raynaud-Syndrome, Vasculitis)
• Inherent connective tissue disease(e.g. Marfan Syndrome)

Trial design

47 participants in 3 patient groups

Perioperative ovarian cancer patients

Pregnant patients

Female healthy volunteers