Cervical InsufficiencyNCT05220839
Relation of the Area of Cerclage With Preterm Birth
An observational study of Cervical Insufficiency, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Insufficiency
- What is being tested?
- Type of cerclage procedure Mc Donald
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2022to 23 Feb 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients aged between 18-45 years old, have not any maternal chronic ilnesses, have not amnion fluid abnormalities, underwent cervical cerclage according to ACOC criteria between 16-23 gestational weeks.
Who may be able to join
- Singleton pregnancy between 16-23 weeks of gestation and between the ages of 18-45
- According to ACOG based on history (Having one or more painless abortions between 16-22 weeks of gestation , a history of cerclage
- According to ACOG based on physical examination ( fetal membranes prolapsed from endocervical canal or not, cervical dilation present )
- Accoding to ACOG based on ultrasound examination ( if there is no previous history of preterm birth , if the cervical length is 10mm or less, if the cervical length is less than 25mm with a history of preterm birth )
Who cannot join
- Multiple pregnancies
- Pregnant women with premature rupture of membranes
- Pregnant women with uterine anomalies
- Pregnant women with fetal anomalies
- Pregnant women with Gestational diabetes mellitus, Chronic or gestational hypertension , fetal growth restriction , oligohydroamnios or polihydroamnios
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik Zubeyde Hanım Women's Health Training and Research hospital
Ankara, Keçiören, 06010
Neval Çayönü Kahraman, MD, +905336212174, nevalcayonu@gmail.com
Mehmet Obut, MD, +905056710339, drmehmetobut@hotmail.com
About this study
Official title: Is the Cerclage Area Associated With the Incidence of Preterm Birth in Pregnant Women Undergoing Mc Donald Cerclage?
This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.
Read the detailed description
The parameters that will be measured with transvaginal ultrasound are:
- Cerclage area in the axial plane of the cervix
- Angle between anterior uterine wall and internal os
- Angle between anterior uterine wall and external os
- Anterior and posterior cervical widht at level of stitch
- Anterior and posterior stitch depth (stitch to canal )
- Cervical length above and below cerclage stitch
Before the data collection phase ,the required sample number for the research was determined using the G*power (Faul, Erdfelder, Buchner, \& Lang, 2009) 3.1 program. When the alpha level is .05 and the power is %95 , the total number of samples was found o be 22.
- Conditions
- Cervical Insufficiency
- Being tested
- Type of cerclage procedure Mc Donald
- Keywords
- cerclage area, incidence of preterm birth, Mc Donald
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of cerclage procedure Mc DonaldProcedure or surgery
Patients who underwent Mc Donald cervical cerclage will be calculated the area of cervical cerclage area
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical cerclage area
cervical cerclage will be measured in the axial plane of the cervix by transvaginal ultrasonography
Measured: Between 16-23 weeks of pregnancy
Preterm birth
The incidence of patients delivered before 37. gestational weeks
Measured: From date of cervical cerclage to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start21 Jan 2022
- Primary completion21 Jan 2023 (estimated)
- Study completion23 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical InsufficiencyStudies 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
- Prospective
- Enrolment
- 22 participants (estimated)
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, Neval Cayonu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Can Tekin Iskender, MD, Study director, Helath Sciences University, Etlik Zubeyde Hanım Women's Health Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220839
- Sponsor's protocol ID
- 2021/132
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahraman N, Obut M. Area of cervical cerclage
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Cerclage Area Associated With the Incidence of Preterm Birth in Pregnant Women Undergoing Mc Donald Cerclage?
- ClinicalTrials.gov ID
- NCT05220839
- Acronym / sponsor ID
- 2021/132
- Conditions
- Cervical Insufficiency
- Keywords
- cerclage area, incidence of preterm birth, Mc Donald
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Jan 2023 (estimated)
- Study completion
- 23 Feb 2023 (estimated)
- First posted
- 2 Feb 2022 (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.
This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.
Detailed description
The parameters that will be measured with transvaginal ultrasound are:
- Cerclage area in the axial plane of the cervix
- Angle between anterior uterine wall and internal os
- Angle between anterior uterine wall and external os
- Anterior and posterior cervical widht at level of stitch
- Anterior and posterior stitch depth (stitch to canal )
- Cervical length above and below cerclage stitch
Before the data collection phase ,the required sample number for the research was determined using the G*power (Faul, Erdfelder, Buchner, \& Lang, 2009) 3.1 program. When the alpha level is .05 and the power is %95 , the total number of samples was found o be 22.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged between 18-45 years old, have not any maternal chronic ilnesses, have not amnion fluid abnormalities, underwent cervical cerclage according to ACOC criteria between 16-23 gestational weeks.
Key inclusion criteria (4 listed)
- Singleton pregnancy between 16-23 weeks of gestation and between the ages of 18-45
- According to ACOG based on history (Having one or more painless abortions between 16-22 weeks of gestation , a history of cerclage
- According to ACOG based on physical examination ( fetal membranes prolapsed from endocervical canal or not, cervical dilation present )
- Accoding to ACOG based on ultrasound examination ( if there is no previous history of preterm birth , if the cervical length is 10mm or less, if the cervical length is less than 25mm with a history of preterm birth )
Key exclusion criteria (5 listed)
- Multiple pregnancies
- Pregnant women with premature rupture of membranes
- Pregnant women with uterine anomalies
- Pregnant women with fetal anomalies
- Pregnant women with Gestational diabetes mellitus, Chronic or gestational hypertension , fetal growth restriction , oligohydroamnios or polihydroamnios
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 |
|---|---|---|
| Type of cerclage procedure Mc DonaldPatients who underwent Mc Donald cervical cerclage will be calculated the area of cervical cerclage area | Procedure or surgery | – |
Primary outcome
cervical cerclage area
Time frame: Between 16-23 weeks of pregnancy
cervical cerclage will be measured in the axial plane of the cervix by transvaginal ultrasonography
Preterm birth
Time frame: From date of cervical cerclage to delivery
The incidence of patients delivered before 37. gestational weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- BackgroundKahraman N, Obut M. Area of cervical cerclage
- my e-mailLink provided by the sponsor.
- 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.
Can Tekin Iskender, MD study director
Helath Sciences University, Etlik Zubeyde Hanım Women's Health Training and Research Hospital
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 Cervical Insufficiency, 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 4 inclusion and 5 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 4 Mar 2022. 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?
Contact Neval Çayönü Kahraman, MD (+905336212174, nevalcayonu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical cerclage area (time frame: Between 16-23 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220839, which also lists 1 linked publication.
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 4 Mar 2022.