UTEROCERVİCAL ANGLE MEASUREMENT IN SPONTANEOUS PRETERM BIRTH (UAMSPB)

NCT ID: NCT03623685

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2019-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Labor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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voluson 8

Group Type EXPERIMENTAL

measurement of uterocervical angle

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meryem Dilara Yetimoğlu

UNKNOWN

Sponsor Role collaborator

İdris Yetimoğlu

UNKNOWN

Sponsor Role collaborator

Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Özkan Özdamar

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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özkan özdamar

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University

Central Contacts

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meryem dilara yetimoğlu

Role: CONTACT

+905422274427

References

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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.

Reference Type BACKGROUND
PMID: 27018466 (View on PubMed)

Other Identifiers

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2017/0343

Identifier Type: -

Identifier Source: org_study_id

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