Uterine Artery NotchNCT01069406
The Association Between Uterine Artery Notch and First Trimester Bleeding
An observational study of Uterine Artery Notch and First Trimester Bleeding, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler. A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Artery Notch, First Trimester Bleeding
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to May 2012
- 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: patients with abnormal uterine artery Doppler at second trimester. pregnant women with eather: elevated HCG and/or aFP at triple test, patients with history of pre eclampsia, IUGR, APD, and patients with thrombophilia.
Who may be able to join
- Patients with abnormal uterine artery Doppler at second trimester
Who cannot join
- Multi fetal pregnancies
- Patients without known gestational age (according to last month period or first trimester ultrasound
- Pregnancies with congenital structural or chromosomal anomalies
- Lack of prenatal care
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.
A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group).The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.
Read the detailed description
The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.
A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group). Both the study group and the control group represent high risk pregnant patients and the Doppler flows are done as part of the patient's predictive risk for placental associated abnormalities. The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.
- Conditions
- Uterine Artery Notch, First Trimester Bleeding
- Keywords
- notch, uterine, first, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| presence of uterine artery notch | patients with uterine artery notch during the 2nd and 3rd trimester |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Artery NotchStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gali Pariente, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069406
- Sponsor's protocol ID
- sor493710CTIL
- Status last verified
- May 2015
- First submitted
- 15 Feb 2010
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Uterine Artery Notch and First Trimester Bleeding
- ClinicalTrials.gov ID
- NCT01069406
- Acronym / sponsor ID
- sor493710CTIL
- Conditions
- Uterine Artery Notch, First Trimester Bleeding
- Keywords
- notch, uterine, first, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- 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.
The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.
A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group).The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.
Detailed description
The purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery Doppler.
A prospective study is designed and two groups will be studied; patients with abnormal uterine artery Doppler at second trimester (study group) and patient with normal uterine artery Doppler at second trimester (control group). Both the study group and the control group represent high risk pregnant patients and the Doppler flows are done as part of the patient's predictive risk for placental associated abnormalities. The patients will be asked, as part of the routine history taken before the US about having first trimester bleeding during the current pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| presence of uterine artery notch | – | –patients with uterine artery notch during the 2nd and 3rd trimester |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with abnormal uterine artery Doppler at second trimester. pregnant women with eather: elevated HCG and/or aFP at triple test, patients with history of pre eclampsia, IUGR, APD, and patients with thrombophilia.
Key inclusion criteria (1 listed)
- Patients with abnormal uterine artery Doppler at second trimester
Key exclusion criteria (4 listed)
- Multi fetal pregnancies
- Patients without known gestational age (according to last month period or first trimester ultrasound
- Pregnancies with congenital structural or chromosomal anomalies
- Lack of prenatal care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 May 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Notch and First Trimester Bleeding, run by Soroka University Medical Center at 1 site in Israel.
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 1 inclusion and 4 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 20 May 2015. 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 Israel. 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.
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 May 2015.