Portal Vein Pulsatility Flow in Pregnancy

NCT04429178 | Completed

• 1 other identifier: 2020-00774; qu19Buddeberg
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

portal vein pulsatility; physiologic volume overload

Outcome Measures

Primary Outcomes (1)

• Portal vein pulsatility fraction (percent)

  Portal vein pulsatility fraction (percent)

  single time-point at baseline

Secondary Outcomes (5)

• Inferior vena cava diameter (mm)

  single time-point at baseline

• Inferior vena cava collapsibility index (percent)

  single time-point at baseline

• Hepatic venous flow (cm/sec)

  single time-point at baseline

• Right atrial and ventricular dimensions (cm)

  single time-point at baseline

• Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)

  single time-point at baseline

Study Arms (4)

women in the 1st trimester of pregnancy.

Other: ultrasound

women in the 2nd trimester of pregnancy.

Other: ultrasound

women in the 3rd trimester of pregnancy.

Other: ultrasound

non-pregnant women

Other: ultrasound

Interventions

ultrasound OTHER

portal vein pulsatility fraction (percent) measured with ultrasound

non-pregnant women; women in the 1st trimester of pregnancy.; women in the 2nd trimester of pregnancy.; women in the 3rd trimester of pregnancy.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anesthesiology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Bigna Buddeberg, Dr. med.

  Department of Anesthesiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: August 13, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

CH (1)