PregnancyNCT04429178
Portal Vein Pulsatility Flow in Pregnancy
An observational study of Pregnancy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- ultrasound
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Aug 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesiology, University Hospital Basel
Basel, 4031
About this study
Official title: 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.
- Conditions
- Pregnancy
- Being tested
- ultrasound
- Keywords
- portal vein pulsatility, physiologic volume overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
portal vein pulsatility fraction (percent) measured with ultrasound
| Study group | Role | What they receive |
|---|---|---|
| women in the 1st trimester of pregnancy. | Not described Receives: Other: ultrasound | |
| women in the 2nd trimester of pregnancy. | Not described Receives: Other: ultrasound | |
| women in the 3rd trimester of pregnancy. | Not described Receives: Other: ultrasound | |
| non-pregnant women | Not described Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein pulsatility fraction (percent)
Portal vein pulsatility fraction (percent)
Measured: single time-point at baseline
Secondary outcomes (5)
Inferior vena cava diameter (mm)
Inferior vena cava diameter (mm)
Measured: single time-point at baseline
Inferior vena cava collapsibility index (percent)
Inferior vena cava collapsibility index (percent)
Measured: single time-point at baseline
Hepatic venous flow (cm/sec)
Hepatic venous flow (cm/sec)
Measured: single time-point at baseline
Right atrial and ventricular dimensions (cm)
Right atrial and ventricular dimensions (cm)
Measured: single time-point at baseline
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Measured: single time-point at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start13 Aug 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bigna Buddeberg, Dr. med., Principal investigator, Department of Anesthesiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429178
- Sponsor's protocol ID
- 2020-00774; qu19Buddeberg
- Status last verified
- Mar 2022
- First submitted
- 9 Jun 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Pulsatility Flow in Pregnancy - a Pilot Study
- ClinicalTrials.gov ID
- NCT04429178
- Acronym / sponsor ID
- 2020-00774; qu19Buddeberg
- Conditions
- Pregnancy
- Keywords
- portal vein pulsatility, physiologic volume overload
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundportal vein pulsatility fraction (percent) measured with ultrasound | Other | non-pregnant women, women in the 1st trimester of pregnancy., women in the 2nd trimester of pregnancy., women in the 3rd trimester of pregnancy. |
Primary outcome
Portal vein pulsatility fraction (percent)
Time frame: single time-point at baseline
Portal vein pulsatility fraction (percent)
5 secondary outcomes
Inferior vena cava diameter (mm)
Time frame: single time-point at baseline
Inferior vena cava collapsibility index (percent)
Time frame: single time-point at baseline
Hepatic venous flow (cm/sec)
Time frame: single time-point at baseline
Right atrial and ventricular dimensions (cm)
Time frame: single time-point at baseline
Tricuspid Annular Plane Systolic Excursion (TAPSE) (mm)
Time frame: single time-point at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bigna Buddeberg, Dr. med. principal investigator
Department of Anesthesiology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein pulsatility fraction (percent) (time frame: single time-point at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.