Cervical Incompetence (Complicating Pregnancy)CCERCIAFAONCT06443112
Pregnancy Outcomes According to Cervical Cerclage Indications and Factors Affecting Pregnancy Duration and Outcomes
An observational study of Cervical Incompetence (Complicating Pregnancy), run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included. The patients were divided into three subgroups for data analysis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Incompetence (Complicating Pregnancy)
- What is being tested?
- transvaginal cervical cerclage by Mc Donald technique
- Type of treatment
- Surgery or procedure
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2024to 10 May 2024
- 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
- No healthy volunteers
- Adult
Study population: 18-45 aged Pregnant women who underwent cerclage at 12-25 weeks gestation from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey.
Who may be able to join
- Pregnants that underwent cervical cerclage between July 2021 and July 2023 with singleton pregnancies
Who cannot join
- Pregnant women without follow-up whose post-procedure data cannot be accessed
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Başakşehir Çam ve Sakura City Hospital
Istanbul, Basaksehir, 34480
About this study
Official title: Pregnancy Outcomes According To Cervical Cerclage Indications And Factors Affecting Pregnancy Duration And Outcomes: A 2-Year Comparison Of Patients Who Underwent History-Based, Ultrasound-Based, or Rescue Cerclage
This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included. The patients were divided into three subgroups for data analysis. Groups included patients with respectively history-indicated cerclage (group 1), ultrasound-indicated cerclage (group 2), and rescue cerclage (group 3). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks.Factors associated with successful cervical cerclage and perinatal outcomes after the procedure for all three groups were analyzed. The investigators also calculated post-cerclage the cervical length cut-off value required to predict if birth could be postponed until after the 28th week of gestation in women with cervical insufficiency.
Read the detailed description
This study retrospectively reviewed data from pregnant women who underwent cerclage from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey. The local ethics committee approved the study.
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki.
The patients were divided into three subgroups for data analysis. Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length (CL) was <25 mm before the 24th week of gestation in the current singleton pregnancy, or who had <10 mm cervical length in the current singleton pregnancy without history. Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No:1 proline. The investigators collected the following data from medical records: maternal age at cervical cerclage, gravidity, parity, body mass index, history of a cervical cone biopsy, history of premature birth and cervical cerclage, procalcitonin level, C-reactive protein (CRP) level, gestational age at cerclage, pre-and post-cerclage CL, week of birth, pregnancy complications (preterm premature rupture of the membranes (PPROM), abruptio placenta, chorioamnionitis). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks. The indications and the pregnancy outcomes (miscarriage, gestational age at delivery, birth weight, prolongation of pregnancy, and rate of preterm birth before 34 weeks) of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed.
Moreover, receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency (CI). Thus, the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
- Being tested
- transvaginal cervical cerclage by Mc Donald technique
- Keywords
- cervical cerclage indications, cervical insufficiency, post-cerclage cervical length, Pregnancy outcomes
- Medical subject headings
- Uterine Cervical Incompetence, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal cervical cerclage by Mc Donald techniqueProcedure or surgery
In the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion.
| Study group | Role | What they receive |
|---|---|---|
| history-indicated cerclage group (group1) | Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. Receives: Procedure: transvaginal cervical cerclage by Mc Donald technique | |
| (Group 2) patients with ultrasound-indicated cerclage | Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length was <25 mm before the 24th week of gestation in the current singleton pregnancy, or who had <10 mm cervical length in the current singleton pregnancy without history. Receives: Procedure: transvaginal cervical cerclage by Mc Donald technique | |
| Group 3 consisted of patients undergoing rescue cerclage | Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. Receives: Procedure: transvaginal cervical cerclage by Mc Donald technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency from the time of cerclage procedure to delivery
Factors affecting time (time in days) elapsed from cerclage procedure to birth were evaluated
Measured: time from cerclage procedure to birth
pre-cerclage and post-cerclage cervical length cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency.
receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL (length in centimeters) cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with CI. Thus, we extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
Measured: time from diagnosis to birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start10 May 2024
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Incompetence (Complicating Pregnancy)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zeynep Kayaoglu yıldırım, MD, Study director, Başakşehir Çam ve Sakura City HospitalElif Sagban Gedik, MD, Principal investigator, Başakşehir Çam ve Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443112
- Sponsor's protocol ID
- BasaksehirCamveSakuraH
- Acronym
- CCERCIAFAO
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song RK, Cha HH, Shin MY, Choi SJ, Oh SY, Kim JH, Roh CR. Post-cerclage ultrasonographic cervical length can predict preterm delivery in elective cervical cerclage patients. Obstet Gynecol Sci. 2016 Jan;59(1):17-23. doi: 10.5468/ogs.2016.59.1.17. Epub 2016 Jan 15.
PubMed 26866031Chan LL, Leung TW, Lo TK, Lau WL, Leung WC. Indications for and pregnancy outcomes of cervical cerclage: 11-year comparison of patients undergoing history-indicated, ultrasound-indicated, or rescue cerclage. Hong Kong Med J. 2015 Aug;21(4):310-7. doi: 10.12809/hkmj144393. Epub 2015 Jul 17.
PubMed 26183455Cook JR, Chatfield S, Chandiramani M, Kindinger L, Cacciatore S, Sykes L, Teoh T, Shennan A, Terzidou V, Bennett PR. Cerclage position, cervical length and preterm delivery in women undergoing ultrasound indicated cervical cerclage: A retrospective cohort study. PLoS One. 2017 Jun 1;12(6):e0178072. doi: 10.1371/journal.pone.0178072. eCollection 2017.
PubMed 28570639
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes According To Cervical Cerclage Indications And Factors Affecting Pregnancy Duration And Outcomes: A 2-Year Comparison Of Patients Who Underwent History-Based, Ultrasound-Based, or Rescue Cerclage
- ClinicalTrials.gov ID
- NCT06443112
- Acronym / sponsor ID
- CCERCIAFAO / BasaksehirCamveSakuraH
- Keywords
- cervical cerclage indications, cervical insufficiency, post-cerclage cervical length, Pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 5 Jun 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.
This study aimed to asses predictive factors associated with successful cervical cerclage and poor pregnancy outcomes in all indications.129 pregnant women who underwent cerclage at 12-25 weeks gestation in a perinatal medical center were included. The patients were divided into three subgroups for data analysis. Groups included patients with respectively history-indicated cerclage (group 1), ultrasound-indicated cerclage (group 2), and rescue cerclage (group 3). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks.Factors associated with successful cervical cerclage and perinatal outcomes after the procedure for all three groups were analyzed. The investigators also calculated post-cerclage the cervical length cut-off value required to predict if birth could be postponed until after the 28th week of gestation in women with cervical insufficiency.
Detailed description
This study retrospectively reviewed data from pregnant women who underwent cerclage from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey. The local ethics committee approved the study.
All procedures followed the relevant guidelines and regulations of the institutional ethics review board and the Declaration of Helsinki.
The patients were divided into three subgroups for data analysis. Group 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. Group 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length (CL) was <25 mm before the 24th week of gestation in the current singleton pregnancy, or who had <10 mm cervical length in the current singleton pregnancy without history. Group 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. All cervical cerclage procedures were performed by a senior obstetrician using the McDonald technique with Mersilene tape or No:1 proline. The investigators collected the following data from medical records: maternal age at cervical cerclage, gravidity, parity, body mass index, history of a cervical cone biopsy, history of premature birth and cervical cerclage, procalcitonin level, C-reactive protein (CRP) level, gestational age at cerclage, pre-and post-cerclage CL, week of birth, pregnancy complications (preterm premature rupture of the membranes (PPROM), abruptio placenta, chorioamnionitis). The investigators defined successful cerclage as postponing birth until after the 28th week of gestation and a 'good outcome' was defined as delivery beyond 34 completed weeks. The indications and the pregnancy outcomes (miscarriage, gestational age at delivery, birth weight, prolongation of pregnancy, and rate of preterm birth before 34 weeks) of cervical cerclage were reviewed and the factors associated with successful cervical cerclage were analyzed.
Moreover, receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency (CI). Thus, the investigators extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| history-indicated cerclage group (group1) | – | Procedure: transvaginal cervical cerclage by Mc Donald techniqueGroup 1 included patients with history-indicated cerclage, who had second-trimester pregnancy loss associated with painless cervical dilatation in the absence of labor or placental abruption, or previous cerclage due to painless cervical dilatation in the second trimester. |
| (Group 2) patients with ultrasound-indicated cerclage | – | Procedure: transvaginal cervical cerclage by Mc Donald techniqueGroup 2 comprised patients with ultrasound-indicated cerclage, who had a history of spontaneous preterm birth before the 34th week previously and their cervical length was <25 mm before the 24th week of gestation in the current singleton pregnancy, or who had <10 mm cervical length in the current singleton pregnancy without history. |
| Group 3 consisted of patients undergoing rescue cerclage | – | Procedure: transvaginal cervical cerclage by Mc Donald techniqueGroup 3 consisted of patients undergoing rescue cerclage, who had premature cervical dilatation and exposure of fetal membranes in the vagina, was detected in ultrasound or speculum examination of the cervix. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 18-45 aged Pregnant women who underwent cerclage at 12-25 weeks gestation from July 2021 to July 2023 in Çam and Sakura City Hospital, which is a perinatal medical center in Istanbul, Turkey.
Key inclusion criteria (1 listed)
- Pregnants that underwent cervical cerclage between July 2021 and July 2023 with singleton pregnancies
Key exclusion criteria (2 listed)
- Pregnant women without follow-up whose post-procedure data cannot be accessed
- Multiple pregnancies
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 |
|---|---|---|
| transvaginal cervical cerclage by Mc Donald techniqueIn the McDonald operation, a suture is is inserted around the exo-cervix as high as possible to approximate to the level of the internal os and thereby prevent second-trimester abortion. | Procedure or surgery | (Group 2) patients with ultrasound-indicated cerclage, Group 3 consisted of patients undergoing rescue cerclage, history-indicated cerclage group (group1) |
Primary outcome
Latency from the time of cerclage procedure to delivery
Time frame: time from cerclage procedure to birth
Factors affecting time (time in days) elapsed from cerclage procedure to birth were evaluated
pre-cerclage and post-cerclage cervical length cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with cervical insufficiency.
Time frame: time from diagnosis to birth
receiver operating characteristic (ROC) curves were used to calculate the pre-cerclage and post-cerclage CL (length in centimeters) cut-off value required to predict if birth could be postponed birth until after the 28th week of gestation in women with CI. Thus, we extracted significant factors for a successful cervical cerclage for long-term pregnancy sustenance in women with CI.
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 5 Jun 2024.
- Results publication: PubMed 26866031Song RK, Cha HH, Shin MY, Choi SJ, Oh SY, Kim JH, Roh CR. Post-cerclage ultrasonographic cervical length can predict preterm delivery in elective cervical cerclage patients. Obstet Gynecol Sci. 2016 Jan;59(1):17-23. doi: 10.5468/ogs.2016.59.1.17. Epub 2016 Jan 15.
- Results publication: PubMed 26183455Chan LL, Leung TW, Lo TK, Lau WL, Leung WC. Indications for and pregnancy outcomes of cervical cerclage: 11-year comparison of patients undergoing history-indicated, ultrasound-indicated, or rescue cerclage. Hong Kong Med J. 2015 Aug;21(4):310-7. doi: 10.12809/hkmj144393. Epub 2015 Jul 17.
- Results publication: PubMed 28570639Cook JR, Chatfield S, Chandiramani M, Kindinger L, Cacciatore S, Sykes L, Teoh T, Shennan A, Terzidou V, Bennett PR. Cerclage position, cervical length and preterm delivery in women undergoing ultrasound indicated cervical cerclage: A retrospective cohort study. PLoS One. 2017 Jun 1;12(6):e0178072. doi: 10.1371/journal.pone.0178072. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Zeynep Kayaoglu yıldırım, MD study director
Başakşehir Çam ve Sakura City Hospital
Elif Sagban Gedik, MD principal investigator
Başakşehir Çam ve Sakura City 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 Incompetence (Complicating Pregnancy), run by Başakşehir Çam & Sakura City 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 2 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 5 Jun 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?
Latency from the time of cerclage procedure to delivery (time frame: time from cerclage procedure to birth). 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 NCT06443112, which also lists 3 linked publications.
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 5 Jun 2024.