Uterine Scar DefectNCT04871022
Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean
A study testing Double layer closure of the hysterotomy and Purse closure of the hysterotomy in people with Uterine Scar Defect, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Scar Defect
- What is being tested?
- Double layer closure of the hysterotomy and Purse closure of the hysterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2021to 1 Jul 2022
- 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 48 years
- Women only
- Healthy volunteers accepted
- 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 10Show fewer
- BMI >35 kg/m2
- Placenta praevia
- Chronic systemic disease
- Covid-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.
This study compares two techniques of uterine closure on myometrium thickness:
Read more
- Double layer unlocked suture;
- Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.
The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
- Conditions
- Uterine Scar Defect
- Being tested
- Double layer closure of the hysterotomy, Purse closure of the hysterotomy
- Keywords
- niche
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double layer closure of the hysterotomyProcedure or surgery
Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.
Purse closure of the hysterotomyProcedure or surgery
Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium
| Study group | Role | What they receive |
|---|---|---|
| Double layer unlocked uterine closer | Active comparator | Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium. Receives: Procedure: Double layer closure of the hysterotomy |
| Purse uterine closer | Experimental | Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium Receives: Procedure: Purse closure of the hysterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual myometrium thickness
Measured: 6 months after intervention
Secondary outcomes (4)
Operative time
Measured: Same day of intervention: day 1
Estimated blood loss
Measured: Same day of intervention: day 1
Mean number of haemostatic sutures
Measured: Same day of intervention: day 1
scar width
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 posted4 May 2021
- Study start15 May 2021
- Primary completion31 Mar 2022
- Study completion1 Jul 2022
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Halouani, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871022
- Sponsor's protocol ID
- UTuniselmanar3
- Status last verified
- Sep 2022
- First submitted
- 28 Apr 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halouani A, Dimassi K, Ben Mansour A, Triki A. Impact of purse-string uterine suture on scar healing after a cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100992. doi: 10.1016/j.ajogmf.2023.100992. Epub 2023 Apr 29.
PubMed 37127211
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean
- ClinicalTrials.gov ID
- NCT04871022
- Acronym / sponsor ID
- UTuniselmanar3
- Conditions
- Uterine Scar Defect
- Keywords
- niche
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 4 May 2021 (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.
There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.
This study compares two techniques of uterine closure on myometrium thickness:
- Double layer unlocked suture;
- Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.
The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double layer unlocked uterine closer | Active comparator | Procedure: Double layer closure of the hysterotomyDouble layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium. |
| Purse uterine closer | Experimental | Procedure: Purse closure of the hysterotomyPurse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Planned cesarean
- Primary cesarean
- ≥ 38 gestational weeks
Key exclusion criteria (10 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 |
|---|---|---|
| Double layer closure of the hysterotomyDouble layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium. | Procedure or surgery | Double layer unlocked uterine closer |
| Purse closure of the hysterotomyPurse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium | Procedure or surgery | Purse uterine closer |
Primary outcome
Residual myometrium thickness
Time frame: 6 months after intervention
4 secondary outcomes
Operative time
Time frame: Same day of intervention: day 1
Estimated blood loss
Time frame: Same day of intervention: day 1
Mean number of haemostatic sutures
Time frame: Same day of intervention: day 1
scar width
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 27 Sep 2022.
- Derived from this study: PubMed 37127211Halouani A, Dimassi K, Ben Mansour A, Triki A. Impact of purse-string uterine suture on scar healing after a cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100992. doi: 10.1016/j.ajogmf.2023.100992. Epub 2023 Apr 29.
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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.
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 Double layer closure of the hysterotomy and Purse closure of the hysterotomy in people with Uterine Scar Defect, run by University Tunis El Manar at 1 site in Tunisia.
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 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 27 Sep 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 Tunisia. 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?
Residual 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 NCT04871022, 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 27 Sep 2022.