Preterm LaborNCT04313673
Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening
An observational study of Preterm Labor, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- second trimester ultrasonography
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2020to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 200 randomized
Who may be able to join
- -Pregnant women who gave birth in our clinic and have a 2nd trimester cervical length measurement
Who cannot join
- uterin anomaly
- multiple pregnancy cases with a history of cervical surgery
- termination of pregnancy due to fetal or maternal reasons
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical Universty Medical School
Trabzon, 61100
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Labor
- Being tested
- second trimester ultrasonography
- Keywords
- ultrasonography, transvaginal, transabdominal, second trimester, preterm labor, predict
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second trimester ultrasonographyDiagnostic test
Patients undergoing routine antenatal screening between 18-24 weeks and measuring cervical length with transabdominal ultrasonography in the same session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: second trimester ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
preterm labor
cases were classified as preterm and term
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start10 Mar 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erhan hüseyin cömert, Karadeniz Technical University
- Investigators
- suleyman guven, professor, Study chair, karadeniz thecnical universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313673
- Sponsor's protocol ID
- GOLEdvlt
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Measurement of Transabdominal Cervical Length Predict Preterm Labor During Routine Antenatal Screening Between Weeks 18-22 ?
- ClinicalTrials.gov ID
- NCT04313673
- Acronym / sponsor ID
- GOLEdvlt
- Conditions
- Preterm Labor
- Keywords
- ultrasonography, transvaginal, transabdominal, second trimester, preterm labor, predict
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| randomized | – | Diagnostic Test: second trimester ultrasonographyPatients 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 randomized
Key inclusion criteria (1 listed)
- -Pregnant women who gave birth in our clinic and have a 2nd trimester cervical length measurement
Key exclusion criteria (3 listed)
- uterin anomaly
- multiple pregnancy cases with a history of cervical surgery
- termination of pregnancy due to fetal or maternal reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| second trimester ultrasonographyPatients undergoing routine antenatal screening between 18-24 weeks and measuring cervical length with transabdominal ultrasonography in the same session | Diagnostic test | randomized |
Primary outcome
preterm labor
Time frame: 2 year
cases were classified as preterm and term
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
suleyman guven, professor study chair
karadeniz thecnical universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preterm labor (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.