Uterine Scar DefectSUTURENCT01860859
Suture of UTerus and Ultrasound Repair Evaluation
A study testing Closure of the hysterotomy at the time of primary cesarean in people with Uterine Scar Defect, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3)… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar Defect
- What is being tested?
- Closure of the hysterotomy at the time of primary cesarean
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Mar 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned cesarean
- Primary cesarean
- ≥ 38 gestational weeks
Who cannot join
- Previous cesarean
- Women < 18 years old
- Multiple gestation
- Mullerian anomalies
- Active labor
- Diabetes
Show all 9Show fewer
- BMI >35 kg/m2
- Placenta praevia
- Chronic systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean
This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
- Conditions
- Uterine Scar Defect
- Being tested
- Closure of the hysterotomy at the time of primary cesarean
- Keywords
- cesarean, ultrasound, hysterotomy, uterus, suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the hysterotomy at the time of primary cesareanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Unlocked double layer | Other | Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. Receives: Procedure: Closure of the hysterotomy at the time of primary cesarean |
| Locked single layer closure | Other | As reported in Williams Obstetrics textbook Receives: Procedure: Closure of the hysterotomy at the time of primary cesarean |
| Locked double layer | Other | Double layer closure with a first continuous locked suture and a second imbricating continuous suture. Receives: Procedure: Closure of the hysterotomy at the time of primary cesarean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean myometrium thickness
Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.
Measured: 6 months after intervention
Secondary outcomes (3)
Estimated blood loss
Measured: Same day of intervention: day 1
Operative time
Measured: Same day of intervention: day 1
Mean number of haemostatic sutures
Measured: Same day of intervention: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uterine Scar DefectStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Université de Montréal
- Responsible party
- Principal investigator, Emmanuel Bujold, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860859
- Sponsor's protocol ID
- C12-03-204
- Acronym
- SUTURE
- Status last verified
- May 2015
- First submitted
- 9 May 2013
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.
PubMed 22399223Roberge S, Chaillet N, Boutin A, Moore L, Jastrow N, Brassard N, Gauthier RJ, Hudic I, Shipp TD, Weimar CH, Fatusic Z, Demers S, Bujold E. Single- versus double-layer closure of the hysterotomy incision during cesarean delivery and risk of uterine rupture. Int J Gynaecol Obstet. 2011 Oct;115(1):5-10. doi: 10.1016/j.ijgo.2011.04.013. Epub 2011 Jul 26.
PubMed 21794864
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean
- ClinicalTrials.gov ID
- NCT01860859
- Acronym / sponsor ID
- SUTURE / C12-03-204
- Conditions
- Uterine Scar Defect
- Keywords
- cesarean, ultrasound, hysterotomy, uterus, suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Laval University, Université de Montréal
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 May 2013 (estimated)
- 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 three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unlocked double layer | Other | Procedure: Closure of the hysterotomy at the time of primary cesareanDouble layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. |
| Locked single layer closure | Other | Procedure: Closure of the hysterotomy at the time of primary cesareanAs reported in Williams Obstetrics textbook |
| Locked double layer | Other | Procedure: Closure of the hysterotomy at the time of primary cesareanDouble layer closure with a first continuous locked suture and a second imbricating continuous suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned cesarean
- Primary cesarean
- ≥ 38 gestational weeks
Key exclusion criteria (9 listed)
- Previous cesarean
- Women < 18 years old
- Multiple gestation
- 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 hysterotomy at the time of primary cesarean | Procedure or surgery | Locked double layer, Locked single layer closure, Unlocked double layer |
Primary outcome
Mean myometrium thickness
Time frame: 6 months after intervention
Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure.
3 secondary outcomes
Estimated blood loss
Time frame: Same day of intervention: day 1
Operative time
Time frame: Same day of intervention: day 1
Mean number of haemostatic sutures
Time frame: Same day of intervention: day 1
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 18 May 2015.
- Background: PubMed 22399223Roberge S, Boutin A, Chaillet N, Moore L, Jastrow N, Demers S, Bujold E. Systematic review of cesarean scar assessment in the nonpregnant state: imaging techniques and uterine scar defect. Am J Perinatol. 2012 Jun;29(6):465-71. doi: 10.1055/s-0032-1304829. Epub 2012 Mar 7.
- Background: PubMed 21794864Roberge S, Chaillet N, Boutin A, Moore L, Jastrow N, Brassard N, Gauthier RJ, Hudic I, Shipp TD, Weimar CH, Fatusic Z, Demers S, Bujold E. Single- versus double-layer closure of the hysterotomy incision during cesarean delivery and risk of uterine rupture. Int J Gynaecol Obstet. 2011 Oct;115(1):5-10. doi: 10.1016/j.ijgo.2011.04.013. Epub 2011 Jul 26.
Related trials for Uterine Scar Defect
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Not yet recruiting
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Caesarean Scar Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
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 hysterotomy at the time of primary cesarean in people with Uterine Scar Defect, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 9 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 18 May 2015. 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 Canada. 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?
Mean myometrium thickness (time frame: 6 months after intervention). 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 NCT01860859, which also lists 2 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 18 May 2015.