Portal Vein Pulsatility Flow in Pregnancy

March 1, 2022 updated by: University Hospital, Basel, Switzerland

Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Anesthesiology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women attending either the anaesthetic preassessment clinic or the obstetric ultrasound clinic at University Hospital Basel.

Non-pregnant healthy females fulfilling the inclusion criteria will be recruited by published advertisement at the University Hospital Basel.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-pregnant women
Other: ultrasound
portal vein pulsatility fraction (percent) measured with ultrasound
women in the 1st trimester of pregnancy.
Other: ultrasound
portal vein pulsatility fraction (percent) measured with ultrasound
women in the 2nd trimester of pregnancy.
Other: ultrasound
portal vein pulsatility fraction (percent) measured with ultrasound
women in the 3rd trimester of pregnancy.
Other: ultrasound
portal vein pulsatility fraction (percent) measured with ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal vein pulsatility fraction (percent)
Time Frame: single time-point at baseline
Portal vein pulsatility fraction (percent)
single time-point at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inferior vena cava diameter (mm)
Time Frame: single time-point at baseline
Inferior vena cava diameter (mm)
single time-point at baseline
Inferior vena cava collapsibility index (percent)
Time Frame: single time-point at baseline
Inferior vena cava collapsibility index (percent)
single time-point at baseline
Hepatic venous flow (cm/sec)
Time Frame: single time-point at baseline
Hepatic venous flow (cm/sec)
single time-point at baseline
Right atrial and ventricular dimensions (cm)
Time Frame: single time-point at baseline
Right atrial and ventricular dimensions (cm)
single time-point at baseline
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Time Frame: single time-point at baseline
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
single time-point at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Bigna Buddeberg, Dr. med., Department of Anesthesiology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-00774; qu19Buddeberg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe