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NCT04429178 Clinical Trial

Portal Vein Pulsatility Flow in Pregnancy

Pregnancy Clinical Trial

Official title:
Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04429178
Other study ID # 2020-00774; qu19Buddeberg
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 13, 2020
Est. completion date March 1, 2022

Study information
Verified date March 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ultrasound
portal vein pulsatility fraction (percent) measured with ultrasound

Locations
Country Name City State
Switzerland Department of Anesthesiology, University Hospital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
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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