UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB) (UAMSPB)
Primary Purpose
Preterm Labor
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
measurement of uterocervical angle
Sponsored by
About this trial
This is an interventional screening trial for Preterm Labor focused on measuring uterocervical angle, preterm labor
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
voluson 8
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03623685
First Posted
July 24, 2018
Last Updated
August 8, 2018
Sponsor
Istanbul Medeniyet University
Collaborators
Meryem Dilara Yetimoğlu, İdris Yetimoğlu
1. Study Identification
Unique Protocol Identification Number
NCT03623685
Brief Title
UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)
Acronym
UAMSPB
Official Title
RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Anticipated)
Primary Completion Date
August 10, 2019 (Anticipated)
Study Completion Date
December 10, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
Collaborators
Meryem Dilara Yetimoğlu, İdris Yetimoğlu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 . 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
uterocervical angle, preterm labor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
voluson 8
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
measurement of uterocervical angle
Intervention Description
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
Primary Outcome Measure Information:
Title
The measurement of patients after they give birth
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
meryem dilara yetimoğlu
Phone
+905422274427
Email
saylardilara@windowslive.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
özkan özdamar
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27018466
Citation
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.
Results Reference
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UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)
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