Preterm LaborUAMSPBNCT03623685
UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)
A study testing measurement of uterocervical angle in people with Preterm Labor, run by Istanbul Medeniyet University.
Trial summary
İn this study Study; Between August 2018 and August 2019, the Ministry of Health, Medeniyet University, Göztepe Training and Research Hospital, Gynecology and Obstetrics Clinic Will be Included for Routine Control Purposes, Single Pregnancies Between 16-24 Weeks and no Known Risk Factors for Preterm Delivery . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- measurement of uterocervical angle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2018to 10 Dec 2019
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who did not have complaints between December 2017 and August 2018, who went to polyclinic because of routine control
- Patients who had a pregnancy between 16-24 weeks
- Patients with singleton pregnancy
- Patients with a cervical length of 25 mm or more
Who cannot join
- Patients with preterm labor history (under 37 weeks) in previous pregnancy
- Patients with premature rupture of membranes in current pregnancy
- Patients with past uterine cervical surgery (conization, LEEP) as a cause of premature birth
- Patients with preterm birth
- Placenta anomalies present pregnancy
- Patient with retrovert uterus, uterine fibroid of lower segment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH
İn this study Study; Between August 2018 and August 2019, the Ministry of Health, Medeniyet University, Göztepe Training and Research Hospital, Gynecology and Obstetrics Clinic Will be Included for Routine Control Purposes, Single Pregnancies Between 16-24 Weeks and no Known Risk Factors for Preterm Delivery . Each Participant Will be Given Written and Verbal Information About the Work and Will be Informed. Uterocervical Angle Measurement; Dorsolithotomy, Using a Sterilized Vaginal Ultrasonic Probe. It Will be Seen That the Distance Between the Internal Cervical os and the External Cervical os is Inclusive of the Cervical Isthmus That Can be Seen With the Anterior Uterine Wall. The First Line Will be Drawn Between the Internal Cervical os and the External Cervical os. The Second Line Will be Drawn as Passing Through the Internal Cervical Ostia, Parallel to the Anterior Uterine Wall. The Angle Between the Two Lines on the Internal Cervical Vertebra Will be Measured. Patients Will be Followed up Until the End of the 37th Gestational Week. The Gestation Week They Are Giving Birth Will be Recorded. Patients Were Then Classified as Before and After 37 Gestational Weeks and Uterocervical Angle Measurements Between 16-24 Gestational Weeks Were Compared.
- Conditions
- Preterm Labor
- Being tested
- measurement of uterocervical angle
- Keywords
- uterocervical angle, preterm labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of uterocervical angleDiagnostic test
We will measure between internal cervikal os and external cervical os. After we will draw a line between anterior uterine wall and internal cervical os. Then we will measure angle between two lines
| Study group | Role | What they receive |
|---|---|---|
| voluson 8 | Experimental | Not described Receives: Diagnostic Test: measurement of uterocervical angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of patients after they give birth
Images were re-measured for uterocervical angle between the lower uterine segment and the cervical canal. Primary outcome was prediction of <37 weeks by uterocervikal angle.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start10 Aug 2018 (estimated)
- Primary completion10 Aug 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Meryem Dilara Yetimoğlu, İdris Yetimoğlu
- Responsible party
- Principal investigator, Özkan Özdamar, Istanbul Medeniyet University
- Investigators
- özkan özdamar, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623685
- Sponsor's protocol ID
- 2017/0343
- Acronym
- UAMSPB
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.
PubMed 27018466
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH
- ClinicalTrials.gov ID
- NCT03623685
- Acronym / sponsor ID
- UAMSPB / 2017/0343
- Conditions
- Preterm Labor
- Keywords
- uterocervical angle, preterm labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Meryem Dilara Yetimoğlu, İdris Yetimoğlu
- Study start
- 10 Aug 2018 (estimated)
- Primary completion
- 10 Aug 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 9 Aug 2018 (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.
İn this study Study; Between August 2018 and August 2019, the Ministry of Health, Medeniyet University, Göztepe Training and Research Hospital, Gynecology and Obstetrics Clinic Will be Included for Routine Control Purposes, Single Pregnancies Between 16-24 Weeks and no Known Risk Factors for Preterm Delivery . Each Participant Will be Given Written and Verbal Information About the Work and Will be Informed. Uterocervical Angle Measurement; Dorsolithotomy, Using a Sterilized Vaginal Ultrasonic Probe. It Will be Seen That the Distance Between the Internal Cervical os and the External Cervical os is Inclusive of the Cervical Isthmus That Can be Seen With the Anterior Uterine Wall. The First Line Will be Drawn Between the Internal Cervical os and the External Cervical os. The Second Line Will be Drawn as Passing Through the Internal Cervical Ostia, Parallel to the Anterior Uterine Wall. The Angle Between the Two Lines on the Internal Cervical Vertebra Will be Measured. Patients Will be Followed up Until the End of the 37th Gestational Week. The Gestation Week They Are Giving Birth Will be Recorded. Patients Were Then Classified as Before and After 37 Gestational Weeks and Uterocervical Angle Measurements Between 16-24 Gestational Weeks Were Compared.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| voluson 8 | Experimental | Diagnostic Test: measurement of uterocervical angle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who did not have complaints between December 2017 and August 2018, who went to polyclinic because of routine control
- Patients who had a pregnancy between 16-24 weeks
- Patients with singleton pregnancy
- Patients with a cervical length of 25 mm or more
Key exclusion criteria (6 listed)
- Patients with preterm labor history (under 37 weeks) in previous pregnancy
- Patients with premature rupture of membranes in current pregnancy
- Patients with past uterine cervical surgery (conization, LEEP) as a cause of premature birth
- Patients with preterm birth
- Placenta anomalies present pregnancy
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 |
|---|---|---|
| measurement of uterocervical angleWe will measure between internal cervikal os and external cervical os. After we will draw a line between anterior uterine wall and internal cervical os. Then we will measure angle between two lines | Diagnostic test | voluson 8 |
Primary outcome
The measurement of patients after they give birth
Time frame: 1 year
Images were re-measured for uterocervical angle between the lower uterine segment and the cervical canal. Primary outcome was prediction of <37 weeks by uterocervikal angle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 27018466Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.
- Individual participant dataSharing planned: No
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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.
özkan özdamar principal investigator
Istanbul Medeniyet University
Questions about this trial
What is this clinical trial studying?
A study testing measurement of uterocervical angle in people with Preterm Labor, run by Istanbul Medeniyet University.
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 6 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact meryem dilara yetimoğlu (+905422274427, saylardilara@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of patients after they give birth (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623685, which also lists 1 linked publication.
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 9 Aug 2018.