Pregnancy Clinical Trial
Official title:
Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study
Verified date | March 2022 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is to investigate if portal vein pulsatility fraction can be measured in pregnancy and if it increases during the course of pregnancy as would be expected by the physiologic increase in blood volume that happens during pregnancy. Portal vein pulsatility fraction is measured in non-pregnant controls and in women in the 1st, 2nd and 3rd trimester of pregnancy.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Ability to give informed consent - American Society of Anesthesiologists (ASA) Class I and II - Singleton pregnancy during 1st, 2nd or 3rd trimester or healthy non-pregnant females of childbearing age as controls Exclusion Criteria: - Inability to give informed consent - Multiple gestation - Significant co-morbidities (e.g. cardiac abnormalities, cardiac dysfunction, arrhythmias, severe asthma, renal insufficiency) - High risk pregnancies (e.g. pre-eclampsia, gestational hypertension, HELLP, gestational diabetes) - Body-Mass-Index (BMI) < 18kg/m2 or >40kg/m2 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Anesthesiology, University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Portal vein pulsatility fraction (percent) | Portal vein pulsatility fraction (percent) | single time-point at baseline | |
Secondary | Inferior vena cava diameter (mm) | Inferior vena cava diameter (mm) | single time-point at baseline | |
Secondary | Inferior vena cava collapsibility index (percent) | Inferior vena cava collapsibility index (percent) | single time-point at baseline | |
Secondary | Hepatic venous flow (cm/sec) | Hepatic venous flow (cm/sec) | single time-point at baseline | |
Secondary | Right atrial and ventricular dimensions (cm) | Right atrial and ventricular dimensions (cm) | single time-point at baseline | |
Secondary | Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm) | Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm) | single time-point at baseline |
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