Labor (Obstetrics)--ComplicationsNCT06558500
Uterocervical Angle Versus Cervical Length as a Predictor of Labor Induction in Term Singleton Pregnancy
An observational study of Labor (Obstetrics)--Complications, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Induction of labor is frequently performed in all obstetric clinics. Failed IOL has been defined in many different ways.Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor (Obstetrics)--Complications
- What is being tested?
- Uterocervical angle
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 2 Aug 2024
- How long will I take part?
- 2 Days
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This prospective observational study was conducted at the Department of Obstetrics and Gynecology, Ankara Etlik Hospital, between June 2024 and August 2024, on 140 term pregnancies admitted for maternal or fetal reasons , planned for labor induction.
Who may be able to join
- 37 weeks and older Nulliparity Live, singular Verteks presentation Cervical opening<3 cm Bishop score<7 Patients not in active action
Who cannot join
- Presence of contraindications to vaginal delivery (pls previa, detached pls...)
- History of previous uterine surgery
- Multiple pregnancies
- Non-vertex presentation
- Uncontrolled HT Uncontrolled DM
- Fetal distress
- Macrosomic fetus Patients in active labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zubeyde Hanım Women's Health Education Hospital
Ankara, 06000
About this study
Official title: Uterocervical and Posterior Cervical Angle Versus Cervical Length and Bishop's Score as a Predictor of Labor Induction in Term Singleton Pregnancy: a Prospective Study
Induction of labor is frequently performed in all obstetric clinics. Failed IOL has been defined in many different ways.Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic. The relationship between the angles between the uterus and cervix and labor has been known for some time.
Read the detailed description
Induction of labor is frequently performed in all obstetric clinics for various indications, with a worldwide spectrum ranging from 1.4 to 35%. Failed IOL has been defined in many different ways. It has been defined as a dilatation of less than 4 cm despite administration of oxytocin for 12 hours±3 hours (target 200-225 MVU or 3 contractions/10 min), induction of labor with oxytocin for at least 12-18 hours (after rupture of membranes) and a latent phase lasting 24 hours or longer, primarily considering fetal and maternal well-being. In some sources, it is defined as failure to achieve regular (e.g. every 3 minutes) uterine contractions and cervical changes with artificial rupture of membranes after at least 6-8 hours of oxytocin maintenance dose. For this reason, various subjective \& ultrasonographic parameters used to predict induction success are of great importance for the evaluation of the cervix. Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic.
The relationship between the angles between the uterus and cervix and labor has been known for some time.
- Conditions
- Labor (Obstetrics)--Complications
- Being tested
- Uterocervical angle
- Keywords
- Nulliparous, labor induction, posterior cervical angle, uterocervical angle, cervical length
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterocervical angleProcedure or surgery
Also called Posterior cervical angle
With the patient in the lithotomy position and empty bladder, care was taken to avoid applying pressure to the cervix with the transvaginal probe. The cervix was aligned in the midline, and the endocervical canal was visualized throughout its length.During cervical measurement, care was taken to ensure that the internal os, external os, and entire endocervical canal were visible in the same image. With the endocervical canal, external os, and internal os linearly displayed on the screen, the angle between the endocervical canal, anterior and posterior uterine segment was measured using the ultrasound's "angle measurement" feature.For the measurement of the uterocervical angle, the first line of the angle was defined along the endocervical canal used for measuring cervical length, and the second line was drawn from the internal os along the anterior uterine segment for a minimum of two centimeters. The angle between these two lines was recorded as the uterocervical angle in the form.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | delivered vaginally with successful induction of labor Receives: Procedure: Uterocervical angle | |
| group 2 | failed induction and delivered with C/S Receives: Procedure: Uterocervical angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of uterocervical angle
The efficacy of uterocervical angle in predicting labor induction success in nulliparous patients at term.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor (Obstetrics)--ComplicationsStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Gizem Yildiz, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Ali Turhan ÇAĞLAR, Study chair, Etlik Zübeyde Hanım EAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558500
- Sponsor's protocol ID
- 2022/113
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterocervical and Posterior Cervical Angle Versus Cervical Length and Bishop's Score as a Predictor of Labor Induction in Term Singleton Pregnancy: a Prospective Study
- ClinicalTrials.gov ID
- NCT06558500
- Acronym / sponsor ID
- 2022/113
- Conditions
- Labor (Obstetrics)--Complications
- Keywords
- Nulliparous, labor induction, posterior cervical angle, uterocervical angle, cervical length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 16 Aug 2024 (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.
Induction of labor is frequently performed in all obstetric clinics. Failed IOL has been defined in many different ways.Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic. The relationship between the angles between the uterus and cervix and labor has been known for some time.
Detailed description
Induction of labor is frequently performed in all obstetric clinics for various indications, with a worldwide spectrum ranging from 1.4 to 35%. Failed IOL has been defined in many different ways. It has been defined as a dilatation of less than 4 cm despite administration of oxytocin for 12 hours±3 hours (target 200-225 MVU or 3 contractions/10 min), induction of labor with oxytocin for at least 12-18 hours (after rupture of membranes) and a latent phase lasting 24 hours or longer, primarily considering fetal and maternal well-being. In some sources, it is defined as failure to achieve regular (e.g. every 3 minutes) uterine contractions and cervical changes with artificial rupture of membranes after at least 6-8 hours of oxytocin maintenance dose. For this reason, various subjective \& ultrasonographic parameters used to predict induction success are of great importance for the evaluation of the cervix. Bishop scoring, which is a traditional and subjective method, is more frequently evaluated with cervical length, which has taken its place in preterm labor, and various ultrasonographic evaluations such as Uterocervical angle (UCA), Posterior cervical angle (PCA), cervical elastography, transvulvar ultrasonography, which have recently increased in popularity, have gained importance and led us to evaluate these parameters in our clinic.
The relationship between the angles between the uterus and cervix and labor has been known for some time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: Uterocervical angledelivered vaginally with successful induction of labor |
| group 2 | – | Procedure: Uterocervical anglefailed induction and delivered with C/S |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective observational study was conducted at the Department of Obstetrics and Gynecology, Ankara Etlik Hospital, between June 2024 and August 2024, on 140 term pregnancies admitted for maternal or fetal reasons , planned for labor induction.
Key inclusion criteria (1 listed)
- 37 weeks and older Nulliparity Live, singular Verteks presentation Cervical opening<3 cm Bishop score<7 Patients not in active action
Key exclusion criteria (7 listed)
- Presence of contraindications to vaginal delivery (pls previa, detached pls...)
- History of previous uterine surgery
- Multiple pregnancies
- Non-vertex presentation
- Uncontrolled HT Uncontrolled DM
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 |
|---|---|---|
| Uterocervical angleAlso: Posterior cervical angleWith the patient in the lithotomy position and empty bladder, care was taken to avoid applying pressure to the cervix with the transvaginal probe. The cervix was aligned in the midline, and the endocervical canal was visualized throughout its length.During cervical measurement, care was taken to ensure that the internal os, external os, and entire endocervical canal were visible in the same image. With the endocervical canal, external os, and internal os linearly displayed on the screen, the angle between the endocervical canal, anterior and posterior uterine segment was measured using the ultrasound's "angle measurement" feature.For the measurement of the uterocervical angle, the first line of the angle was defined along the endocervical canal used for measuring cervical length, and the second line was drawn from the internal os along the anterior uterine segment for a minimum of two centimeters. The angle between these two lines was recorded as the uterocervical angle in the form. | Procedure or surgery | group 1, group 2 |
Primary outcome
The efficacy of uterocervical angle
Time frame: 2 days
The efficacy of uterocervical angle in predicting labor induction success in nulliparous patients at term.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
Ali Turhan ÇAĞLAR study chair
Etlik Zübeyde Hanım EAH
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 Labor (Obstetrics)--Complications, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital 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 7 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: finished, as of the sponsor's last update on 20 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The efficacy of uterocervical angle (time frame: 2 days). 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 20 Aug 2024.