Cesarean Section; DehiscenceNCT04198324
Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
A study testing Closure of the uterus with endometrium at the time of cesarean and Closure of the uterus without endometrium at the time of cesarean in people with Cesarean Section; Dehiscence and Cesarean Wound; Dehiscence, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence, Cesarean Wound; Dehiscence
- What is being tested?
- Closure of the uterus with endometrium at the time of cesarean and Closure of the uterus without endometrium at the time of cesarean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2019to 14 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Term pregnancy (≥37 weeks of gestation)
- Singleton pregnancy
- Primary cesarean
Who cannot join
- Previous cesarean section
- Previous uterine surgery
- Multiple gestations
- Mullerian anomalies
- Active labor
- Placenta previa/accreta
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
Read the detailed description
Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.
- Being tested
- Closure of the uterus with endometrium at the time of cesarean, Closure of the uterus without endometrium at the time of cesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the uterus with endometrium at the time of cesareanProcedure or surgery
Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.
Closure of the uterus without endometrium at the time of cesareanProcedure or surgery
Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.
| Study group | Role | What they receive |
|---|---|---|
| Entire fold uterine closure | Active comparator | The uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium. Receives: Procedure: Closure of the uterus with endometrium at the time of cesarean |
| Non-endometrial uterine closure | Experimental | The uterus will be sewn with locked sutures that pass through myometrium without endometrium. Receives: Procedure: Closure of the uterus without endometrium at the time of cesarean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with isthmocele six month after cesarean section
Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography
Measured: 6 months after intervention
Mean myometrium thickness
Myometrial thickness measured at incision site with transvaginal ultrasonography
Measured: 6 months after intervention
Secondary outcomes (1)
Spotting
The rate of spotting complains of patients
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start16 Dec 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
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 Cesarean Section; DehiscenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Closure of the hysterotomy at the time of primary cesarean section
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- Şener Gezer, M.D, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198324
- Sponsor's protocol ID
- KIA 2019/94
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
- ClinicalTrials.gov ID
- NCT04198324
- Acronym / sponsor ID
- KIA 2019/94
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 13 Dec 2019 (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 compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.
Detailed description
Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Closure of the hysterotomy at the time of primary cesarean section
| Arm | Type | Receives |
|---|---|---|
| Entire fold uterine closure | Active comparator | Procedure: Closure of the uterus with endometrium at the time of cesareanThe uterus will be sewn with full fold locked sutures that pass through myometrium and endometrium. |
| Non-endometrial uterine closure | Experimental | Procedure: Closure of the uterus without endometrium at the time of cesareanThe uterus will be sewn with locked sutures that pass through myometrium without endometrium. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Term pregnancy (≥37 weeks of gestation)
- Singleton pregnancy
- Primary cesarean
Key exclusion criteria (6 listed)
- Previous cesarean section
- Previous uterine surgery
- Multiple gestations
- Mullerian anomalies
- Active labor
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 |
|---|---|---|
| Closure of the uterus with endometrium at the time of cesareanClosure of the uterus at the time of primary cesarean will be performed with suturing the endometrium. | Procedure or surgery | Entire fold uterine closure |
| Closure of the uterus without endometrium at the time of cesareanClosure of the uterus at the time of primary cesarean will be performed without suturing the endometrium. | Procedure or surgery | Non-endometrial uterine closure |
Primary outcome
Number of patients with isthmocele six month after cesarean section
Time frame: 6 months after intervention
Residual myometrium thickness of less then 2.5 mm with transvaginal ultrasonography
Mean myometrium thickness
Time frame: 6 months after intervention
Myometrial thickness measured at incision site with transvaginal ultrasonography
1 secondary outcome
Spotting
Time frame: 6 months after intervention
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 16 Dec 2020.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section; Dehiscence
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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.
Şener Gezer, M.D principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the uterus with endometrium at the time of cesarean and Closure of the uterus without endometrium at the time of cesarean in people with Cesarean Section; Dehiscence and Cesarean Wound; Dehiscence, run by Kocaeli 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 3 inclusion and 6 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 16 Dec 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?
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?
Number of patients with isthmocele six month after cesarean section (time frame: 6 months after intervention). 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 NCT04198324, 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 16 Dec 2020.