NCT03623685

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

July 24, 2018

Last Update Submit

August 8, 2018

Conditions

Preterm Labor

Keywords

uterocervical anglepreterm labor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

voluson 8

EXPERIMENTAL
Diagnostic Test: measurement of uterocervical angle

Interventions

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

voluson 8

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 27018466BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • özkan özdamar

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

meryem dilara yetimoğlu

CONTACT

+905422274427saylardilara@windowslive.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 9, 2018

Study Start

August 10, 2018

Primary Completion

August 10, 2019

Study Completion

December 10, 2019

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share