Uterine Artery FlowNCT03064698
Uterine Artery Doppler Changes
An observational study of Uterine Artery Flow, run by Unity Health Toronto at 1 site in Canada.
Trial summary
In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural changes that result in a low resistance in the uterine arteries as pregnancy progresses. In many pregnancies complicated with preeclampsia, growth restriction and other placental related complication, the described change does not… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Artery Flow
- What is being tested?
- Post-partum Doppler ultrasound
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Sep 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with singleton pregnancies.
Who may be able to join
- Women who underwent UA Doppler assessment at 18-22 weeks gestation.
- Viable singleton pregnancy at the time of UA Doppler assessment at 18-22 weeks gestation.
- Is at least 6 weeks postpartum following a livebirth of the aforementioned pregnancy
- Not pregnant at time of post-partum UA Doppler assessment
Who cannot join
- Women will be excluded if they do not meet the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Artery Doppler Changes From the Second Trimester of Pregnancy to the Postpartum Period in a Group of High Risk Women
In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural changes that result in a low resistance in the uterine arteries as pregnancy progresses.
In many pregnancies complicated with preeclampsia, growth restriction and other placental related complication, the described change does not occur. In pregnancies at high risk for placental complications, doppler measurement of Uterine artery flow has been shown to be a reliable predictor of complications.
Read more
Postpartum there is a reversal of vascular changes seen in normal pregnancies. It is unclear if there is a full reversal of these changes in complicated pregnancies with abnormal flow during pregnancy.
The investigators hypothesize that Doppler uterine artery measurements after complicated pregnancies will show some abnormality compared to doppler measurements following uncomplicated pregnancies.
Read the detailed description
The postpartum reversal of pregnancy-related changes in uterine artery (UA) flow is not well documented.
While long-term vascular changes have been noted in women with prior preeclampsia (PE), and in a dose- dependent manner, long-term changes to UA vascular resistance following PE have not been analyzed. Moreover, regardless of whether they experienced PE or intrauterine growth restriction (IUGR), it is not known if women with elevated UA pulsatility index (PI) in mid-pregnancy have higher UA well after pregnancy, compared to women whose UA PI was normal in mid-pregnancy.
The investigators propose to evaluate if UA flow remains abnormally high postpartum in women who had elevated UA flow mid-pregnancy, compared to women whose UA flow was normal in mid-pregnancy.
This is an observational prospective study. The study recruits women that have recently delivered and have undergone a Uterine Doppler ultra sound (US) during the second trimester of their pregnancy. Eligible women will undergo one post-partum ultrasound examination.
- Conditions
- Uterine Artery Flow
- Being tested
- Post-partum Doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-partum Doppler ultrasoundOther
Participants will undergo one uterine artery Doppler ultrasound at 6 weeks post-partum.
| Study group | Role | What they receive |
|---|---|---|
| Normal second trimester Doppler | This group consists of women who had normal doppler ultrasound results at second trimester Receives: Other: Post-partum Doppler ultrasound | |
| Abnormal second trimester Doppler | This group consists of women who had abnormal doppler ultrasound results at second trimester Receives: Other: Post-partum Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in uterine artery flow
Uterine artery flow measurements during pregnancy and after, as measured by Doppler ultrasound
Measured: 2nd trimester (between 13 to 22 weeks gestation) and 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Artery FlowStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Berger, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064698
- Sponsor's protocol ID
- 16-035
- Status last verified
- Oct 2020
- First submitted
- 13 Feb 2017
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Doppler Changes From the Second Trimester of Pregnancy to the Postpartum Period in a Group of High Risk Women
- ClinicalTrials.gov ID
- NCT03064698
- Acronym / sponsor ID
- 16-035
- Conditions
- Uterine Artery Flow
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Feb 2017 (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.
In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural changes that result in a low resistance in the uterine arteries as pregnancy progresses.
In many pregnancies complicated with preeclampsia, growth restriction and other placental related complication, the described change does not occur. In pregnancies at high risk for placental complications, doppler measurement of Uterine artery flow has been shown to be a reliable predictor of complications.
Postpartum there is a reversal of vascular changes seen in normal pregnancies. It is unclear if there is a full reversal of these changes in complicated pregnancies with abnormal flow during pregnancy.
The investigators hypothesize that Doppler uterine artery measurements after complicated pregnancies will show some abnormality compared to doppler measurements following uncomplicated pregnancies.
Detailed description
The postpartum reversal of pregnancy-related changes in uterine artery (UA) flow is not well documented.
While long-term vascular changes have been noted in women with prior preeclampsia (PE), and in a dose- dependent manner, long-term changes to UA vascular resistance following PE have not been analyzed. Moreover, regardless of whether they experienced PE or intrauterine growth restriction (IUGR), it is not known if women with elevated UA pulsatility index (PI) in mid-pregnancy have higher UA well after pregnancy, compared to women whose UA PI was normal in mid-pregnancy.
The investigators propose to evaluate if UA flow remains abnormally high postpartum in women who had elevated UA flow mid-pregnancy, compared to women whose UA flow was normal in mid-pregnancy.
This is an observational prospective study. The study recruits women that have recently delivered and have undergone a Uterine Doppler ultra sound (US) during the second trimester of their pregnancy. Eligible women will undergo one post-partum ultrasound examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal second trimester Doppler | – | Other: Post-partum Doppler ultrasoundThis group consists of women who had normal doppler ultrasound results at second trimester |
| Abnormal second trimester Doppler | – | Other: Post-partum Doppler ultrasoundThis group consists of women who had abnormal doppler ultrasound results at second trimester |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with singleton pregnancies.
Key inclusion criteria (4 listed)
- Women who underwent UA Doppler assessment at 18-22 weeks gestation.
- Viable singleton pregnancy at the time of UA Doppler assessment at 18-22 weeks gestation.
- Is at least 6 weeks postpartum following a livebirth of the aforementioned pregnancy
- Not pregnant at time of post-partum UA Doppler assessment
Key exclusion criteria (1 listed)
- Women will be excluded if they do not meet the above criteria
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 |
|---|---|---|
| Post-partum Doppler ultrasoundParticipants will undergo one uterine artery Doppler ultrasound at 6 weeks post-partum. | Other | Abnormal second trimester Doppler, Normal second trimester Doppler |
Primary outcome
Change in uterine artery flow
Time frame: 2nd trimester (between 13 to 22 weeks gestation) and 6 weeks post-partum
Uterine artery flow measurements during pregnancy and after, as measured by Doppler ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: No
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.
Howard Berger, MD principal investigator
Unity Health Toronto
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 Uterine Artery Flow, run by Unity Health Toronto at 1 site in Canada.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. 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 Canada. 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?
Results are not available in the source record.
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?
Change in uterine artery flow (time frame: 2nd trimester (between 13 to 22 weeks gestation) and 6 weeks post-partum). 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 20 Oct 2020; AzTrials last refreshed its copy on 2 Nov 2026.