Cesarean Section; ComplicationsNCT01289262
Long Term Comparison of Two Different Techniques of Uterine Cesarean Incision Closure
A study testing Purse string closure technique and Continuously locked closure technique in people with Cesarean Section; Complications and Placenta Previa, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section; Complications, Placenta Previa, Placenta Accreta
- What is being tested?
- Purse string closure technique and Continuously locked closure technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
Who cannot join
- Being in active phase of labor
- Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
- Having a history of uterine surgery (myomectomy, hysterotomy) other than CS
- Extension of Kerr incision
- Multiple pregnancy
- Maternal diabetes mellitus
Show all 10Show fewer
- Maternal connective tissue disease
- Uterine malformation
- Uterine fibroids on Kerr incision line
- Chorioamnionitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Institutes of Turkey ISTANBUL, TURKEY
Istanbul
About this study
Official title: Long Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
Read the detailed description
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used.
Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.
- Being tested
- Purse string closure technique, Continuously locked closure technique
- Keywords
- Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS
- Medical subject headings
- Placenta Previa, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse string closure techniqueProcedure or surgery
Also called Uterine incision in C/S
Uterine incision will be closed with purse string closure technique.
Continuously locked closure techniqueProcedure or surgery
Also called Uterine incision in C/S
Uterine incision will be closed with continuously locked closure technique
| Study group | Role | What they receive |
|---|---|---|
| Purse string closure technique | Active comparator | Uterine Kerr incision will be closed with purse string suture. Receives: Procedure: Purse string closure technique |
| Continuously locked closure technique | Active comparator | Uterine Kerr incision will be closed with continuously locked closure technique. Receives: Procedure: Continuously locked closure technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placenta Previa
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Measured: Subsequent pregnancy within next average 6 years
Secondary outcomes (3)
Placenta Insertion Anomalies
It will be noted whether placenta insertion anomalies (placenta accreta and others) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Measured: Subsequent pregnancy within next average 6 years
Uterine Rupture
It will be noted whether uterine rupture (incomplete or complete, dehiscence of uterine incision) in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Measured: Subsequent pregnancy within next average 6 years
Intra-abdominal Adhesions
It will be noted whether intra-abdominal adhesion in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
Measured: Up to average 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2017
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Cem Turan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Cem Turan, Study director, Health Institutes of Turkey ISTANBUL, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289262
- Sponsor's protocol ID
- Kartal2
- Other IDs
- 21.01.2011-02 (02)
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2011
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Turan C. Long-term follow-up of purse-string double-layer closure (Turan technique) for repairing the uterine incision during cesarean delivery. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101212. doi: 10.1016/j.ajogmf.2023.101212. Epub 2023 Nov 2. No abstract available.
PubMed 37925053
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Comparison of Double Layer Continuously Locked Closure of Uterine Incision in Cesarean Section Versus Double Layer Purse String Closure (Turan Technique): A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01289262
- Acronym / sponsor ID
- Kartal2
- Keywords
- Cesarean section, Kerr incision, Purse string suturing in CS, Continuous locked suturing in CS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cesarean section (C/S) is an operation most commonly performed in Obstetrics and Gynecology Clinics. Complications related with incomplete healing of Kerr uterine incision after C/S (adhesions, separation (dehiscence), endometritis, endometriosis, anomalous placentation in subsequent pregnancies, incomplete or complete uterine rupture in subsequent pregnancies, ...) are very important issues. Classically Kerr incision is repaired with continuous locked suturing. Purse string suturing of Kerr incision may reduce the size of the incision and in turn may reduce short and long term complications. For this reason, the investigators aimed to compare two closure techniques.
Detailed description
In the clinic, patients undergoing cesarean section that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups (computer-assisted randomization method will be used.) In the first group of patients classical closure method of Kerr incision(double layered continuously locked suturing) will be used. In the second group of patients double layered purse string closure technique will be used.
Women will be followed for a subsequent pregnancy in the next average 6 years. If they become pregnant again they will be followed up during pregnancy for comparison of long-term effects of the two suture techniques. Patients will be followed especially from the aspects of placental anomalies. Presence of intra-abdominal adhesions, uterine dehiscence, placenta previa, placental invasion anomalies (eg, placenta accreta and others)and incomplete or complete rupture will be compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Purse string closure technique | Active comparator | Procedure: Purse string closure techniqueUterine Kerr incision will be closed with purse string suture. |
| Continuously locked closure technique | Active comparator | Procedure: Continuously locked closure techniqueUterine Kerr incision will be closed with continuously locked closure technique. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Term (> 37 weeks) pregnancy
- Cervical dilatation < 4 cm
- Kerr incision
- Age > 18 years old
Key exclusion criteria (10 listed)
- Being in active phase of labor
- Emergency situations (fetal distress, cord prolapse, placental abruption,severe pre-eclampsia, eclampsia, placenta previa, vasa previa )
- Having a history of uterine surgery (myomectomy, hysterotomy) other than CS
- Extension of Kerr incision
- Multiple pregnancy
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 |
|---|---|---|
| Purse string closure techniqueAlso: Uterine incision in C/SUterine incision will be closed with purse string closure technique. | Procedure or surgery | Purse string closure technique |
| Continuously locked closure techniqueAlso: Uterine incision in C/SUterine incision will be closed with continuously locked closure technique | Procedure or surgery | Continuously locked closure technique |
Primary outcome
Placenta Previa
Time frame: Subsequent pregnancy within next average 6 years
It will be noted whether placenta previa in cesarean operation of the subsequent pregnancy within next average 6 years, and two groups will be compared.
3 secondary outcomes
Placenta Insertion Anomalies
Time frame: Subsequent pregnancy within next average 6 years
Uterine Rupture
Time frame: Subsequent pregnancy within next average 6 years
Intra-abdominal Adhesions
Time frame: Up to average 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37925053Turan C. Long-term follow-up of purse-string double-layer closure (Turan technique) for repairing the uterine incision during cesarean delivery. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101212. doi: 10.1016/j.ajogmf.2023.101212. Epub 2023 Nov 2. No abstract available.
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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.
Cem Turan study director
Health Institutes of Turkey ISTANBUL, TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purse string closure technique and Continuously locked closure technique in people with Cesarean Section; Complications and Placenta Previa, run by Dr. Lutfi Kirdar Kartal 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 5 inclusion and 10 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 19 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?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Placenta Previa (time frame: Subsequent pregnancy within next average 6 years). 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 NCT01289262, 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 19 Aug 2024.