UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)

Preterm Labor Clinical Trial

— UAMSPB  

Official title:

RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03623685
• Other study ID #: 2017/0343
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: August 2018
• Source: Istanbul Medeniyet University
• Contact: meryem dilara yetimoglu
• Phone: +905422274427
• Email: saylardilara[@]windowslive.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: December 10, 2019
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Patients who did not have complaints between December 2017 and August 2018, who went to polyclinic because of routine control

2. Patients who had a pregnancy between 16-24 weeks

3. Patients with singleton pregnancy

4. Patients with a cervical length of 25 mm or more

Exclusion Criteria:

1. Patients with preterm labor history (under 37 weeks) in previous pregnancy

2. Patients with premature rupture of membranes in current pregnancy

3. Patients with past uterine cervical surgery (conization, LEEP) as a cause of premature birth

4. Patients with preterm birth

5. Placenta anomalies present pregnancy

6. Patient with retrovert uterus, uterine fibroid of lower segment

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Diagnostic Test:
• measurement of uterocervical angle
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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Idris Yetimoglu, Meryem Dilara Yetimoglu

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year