NCT04313673

Brief Summary

Sonographically, cervical length measurement is widely used in obstetrics. Studies have revealed that early detection of short cervix can be a predictor of predicting preterm labor. Transvaginal ultrasonography has been shown as a reference method for the recognition of the short cervix, as well as it may be useful in the transabdominal evaluation in the studies conducted. In addition to the advantages of transvaginal evaluation, it is time consuming and disadvantages of some women during anxiety and discomfort during this procedure. Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal. The aim of this study is to investigate the value of the cervical length measured by transabdominal route, which is a more acceptable method for pregnant women, in predicting preterm birth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 10, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 15, 2020

Last Update Submit

March 17, 2020

Conditions

Keywords

ultrasonographytransvaginaltransabdominalsecond trimesterpreterm laborpredict

Outcome Measures

Primary Outcomes (1)

  • preterm labor

    cases were classified as preterm and term

    2 year

Study Arms (1)

randomized

Patients who were followed up in our clinic with a diagnosis of preterm labor that spontaneously took action and were born before 37 weeks of gestation will form a group.

Diagnostic Test: second trimester ultrasonography

Interventions

Patients undergoing routine antenatal screening between 18-24 weeks and measuring cervical length with transabdominal ultrasonography in the same session

randomized

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailson pregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 randomized

You may qualify if:

  • Pregnant women who gave birth in our clinic and have a 2nd trimester cervical length measurement

You may not qualify if:

  • uterin anomaly
  • multiple pregnancy cases with a history of cervical surgery
  • termination of pregnancy due to fetal or maternal reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical Universty Medical School

Trabzon, 61100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • suleyman guven, professor

    karadeniz thecnical universty

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

March 15, 2020

First Posted

March 18, 2020

Study Start

March 10, 2020

Primary Completion

June 30, 2020

Study Completion

July 30, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations