Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening

March 17, 2020 updated by: erhan hüseyin cömert, Karadeniz Technical University

Can the Measurement of Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening Between Weeks 18-22 ?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Births that occur before 37th gestational week are an important cause of perinatal morbidity and mortality. Preterm birth accounts for about 12% of all births. Early screening and correct management of pregnant women at risk of preterm birth is essential in reducing perinatal mortality and morbidity associated with prematurity. But the precise prediction and prevention of preterm birth is still an important research topic.

Transabdominal ultrasonography, which provides a non-invasive evaluation, is more preferred by some patients than transvaginal.The aim of this study was 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Trabzon, Turkey, 61100
        • Karadeniz Technical Universty Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

200 randomized

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preterm labor
Time Frame: 2 year
cases were classified as preterm and term
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Study Chair: suleyman guven, professor, karadeniz thecnical universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOLEdvlt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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