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Completed

NCT Number: NCT04429178

Portal Vein Pulsatility Flow in Pregnancy

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.

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Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesiology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

portal vein pulsatility fraction (percent) measured with ultrasound

Primary outcomes

  1. Portal vein pulsatility fraction (percent)

    Time frame: single time-point at baseline

    Portal vein pulsatility fraction (percent)

Secondary outcomes

  1. Inferior vena cava diameter (mm)

    Time frame: single time-point at baseline

    Inferior vena cava diameter (mm)

  2. Inferior vena cava collapsibility index (percent)

    Time frame: single time-point at baseline

    Inferior vena cava collapsibility index (percent)

  3. Hepatic venous flow (cm/sec)

    Time frame: single time-point at baseline

    Hepatic venous flow (cm/sec)

  4. Right atrial and ventricular dimensions (cm)

    Time frame: single time-point at baseline

    Right atrial and ventricular dimensions (cm)

  5. Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)

    Time frame: single time-point at baseline

    Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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