Portal Vein Pulsatility Flow in Pregnancy

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT04429178
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Other: ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study
• Actual Study Start Date: Aug 13, 2020
• Actual Primary Completion Date: Mar 1, 2022
• Actual Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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
non-pregnant women	Other: ultrasound; portal vein pulsatility fraction (percent) measured with ultrasound

Outcome Measures

Primary Outcome Measures

1. Portal vein pulsatility fraction (percent) [single time-point at baseline]

   Portal vein pulsatility fraction (percent)

Secondary Outcome Measures

1. Inferior vena cava diameter (mm) [single time-point at baseline]

   Inferior vena cava diameter (mm)

2. Inferior vena cava collapsibility index (percent) [single time-point at baseline]

   Inferior vena cava collapsibility index (percent)

3. Hepatic venous flow (cm/sec) [single time-point at baseline]

   Hepatic venous flow (cm/sec)

4. Right atrial and ventricular dimensions (cm) [single time-point at baseline]

   Right atrial and ventricular dimensions (cm)

5. Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm) [single time-point at baseline]

   Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04429178
• Other Study ID Numbers: 2020-00774; qu19Buddeberg
• First Posted: Jun 12, 2020
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: portal vein pulsatility; physiologic volume overload

Study Results

No Results Posted as of Mar 2, 2022