Portal Vein Pulsatility Flow in Pregnancy

Completed

• Conditions: Pregnancy
• Interventions: Other: ultrasound

• Registration Number: NCT04429178
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-12
• Study Start: 2020-08-13
• Status Verified: 2022-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women in the 1st trimester of pregnancy.	ultrasound	-
women in the 2nd trimester of pregnancy.	ultrasound	-
non-pregnant women	ultrasound	-
women in the 3rd trimester of pregnancy.	ultrasound	-

Primary Outcome Measures

Name	Time	Method
Portal vein pulsatility fraction (percent)	single time-point at baseline	Portal vein pulsatility fraction (percent)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology, University Hospital Basel; 🇨🇭 Basel, Switzerland