Clinical trial NCT03623685: UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)
Official title: RANDOMİZED , PROSPEKTİVE COHORT STUDY FOR UTEROCERVİCAL ANGLE MEASUREMENT BY ULTRASOUND FOR PREDİCTİNG SPONTANEOUS PRETERM BİRTH
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Labor
Keywords: uterocervical angle
preterm labor
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Meryem Dilara Yetimoğlu
name: İdris Yetimoğlu
First posted: 2018-08-09
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: The measurement of patients after they give birth
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Medeniyet University
name: özkan özdamar
role: PRINCIPAL_INVESTIGATOR
References:
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.