IsthmoceleDISSUCNCT07608874
Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
A study testing Single-Layered Non-Locked Closure with Decidual Inclusion and Single-Layered Non-Locked Closure with Decidual Sparing in people with Isthmocele and Cesarean Scar Diverticula, run by Kantonsspital Baden at 1 site in Switzerland.
Trial summary
This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Isthmocele, Cesarean Scar Diverticula
- What is being tested?
- Single-Layered Non-Locked Closure with Decidual Inclusion and Single-Layered Non-Locked Closure with Decidual Sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jun 2026to 30 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Who cannot join
- Placenta previa
- Maternal substance abuse or infection
- Suspected placenta accreta
- Diabetes
- one or more prior cesarean section
- Vulnerable participants (e.g., mental health conditions)
- Emergency cesarean sections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baden
Baden, Canton of Aargau, 5400
Amr S. Hamza, Assoc. Prof., +41564863513, amr.hamza@ksb.ch
Leonhard Schaeffer, Prof., +41564863506, leonhard.schaeffer@ksb.ch
About this study
Official title: The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.
Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.
Read the detailed description
Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.
This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.
Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.
- Conditions
- Isthmocele, Cesarean Scar Diverticula
- Being tested
- Single-Layered Non-Locked Closure with Decidual Inclusion, Single-Layered Non-Locked Closure with Decidual Sparing
- Keywords
- isthmocele, Uterine closure techniques, Decidual inclusion, Decidual sparing, Cesarean section, Scar thickness, Niche formation, Sonography, Dyspareunia
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Layered Non-Locked Closure with Decidual InclusionProcedure or surgery
During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar.
Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health.
Single-Layered Non-Locked Closure with Decidual SparingProcedure or surgery
Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue.
Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications.
| Study group | Role | What they receive |
|---|---|---|
| Decidual Inclusion Closure | Experimental | Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture. All other operative steps will be performed according to the standardized study protocol. Receives: Procedure: Single-Layered Non-Locked Closure with Decidual Inclusion |
| Decidual Sparing Closure | Experimental | Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture. All other operative steps will be performed according to the standardized study protocol. Receives: Procedure: Single-Layered Non-Locked Closure with Decidual Sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a cesarean scar niche measured by ultrasound
Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound. The outcome will be reported as the proportion of participants with a niche in each treatment group.
Measured: 6 to 9 months post-operation
Secondary outcomes (17)
Operative time
Operative time in minutes
Measured: Periprocedural
Need for additional sutures for hemostasis
Need for additional hemostatic sutures, yes (how many: __ Number) /no
Measured: Periprocedural
Length of hospital stay
Length of postoperative hospital stay in days
Measured: Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Measured: Postoperative day 2
Postoperative bleeding
Clinically relevant postoperative bleeding, yes/no
Measured: Postoperative day 2
Wound infection
Postoperative wound infection, yes/no
Measured: Postoperative day 2
Postoperative fever
Postoperative fever, yes/no
Measured: Postoperative day 2
Abnormal uterine bleeding
Abnormal uterine bleeding reported at follow-up, yes/no
Measured: 6 to 9 months post-operation
Dysmenorrhea
Dysmenorrhea reported at follow-up, yes/no
Measured: 6 to 9 months post-operation
Chronic pelvic pain
Chronic pelvic pain reported at follow-up, yes/no
Measured: 6 to 9 months post-operation
Dyspareunia
Dyspareunia reported at follow-up, yes/no
Measured: 6 to 9 months post-operation
Cesarean scar niche length measured by ultrasound in mm
Length of cesarean scar niche in mm measured by ultrasound.
Measured: 6 to 9 months post-operation
Cesarean scar niche depth measured by ultrasound in mm
Depth of cesarean scar niche in mm measured by ultrasound.
Measured: 6 to 9 months post-operation
Cesarean scar niche width measured by ultrasound in mm
Width of cesarean scar niche in mm measured by ultrasound.
Measured: 6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
Residual myometrial thickness measured by ultrasound in mm
Measured: 6 to 9 months post-operation
Presence of intrauterine fluid on ultrasound
Presence or absence of intrauterine fluid on ultrasound.
Measured: 6 to 9 months post-operation
Residual-to-adjacent myometrial thickness ratio
Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
Measured: 6 to 9 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start17 Jun 2026
- Primary completion1 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Sherif Hamza, Kantonsspital Baden
- Investigators
- Amr S. Hamza, Assoc. Prof., Principal investigator, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608874
- Sponsor's protocol ID
- StudyKSBHAM001
- Acronym
- DISSUC
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared outside the research team because no external data-sharing process has been approved by the ethics committee or institution. Aggregate study results may be shared through publication or presentation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07608874
- Acronym / sponsor ID
- DISSUC / StudyKSBHAM001
- Conditions
- Isthmocele, Cesarean Scar Diverticula
- Keywords
- isthmocele, Uterine closure techniques, Decidual inclusion, Decidual sparing, Cesarean section, Scar thickness, Niche formation, Sonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 27 May 2026 (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 two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.
Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.
Detailed description
Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.
This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.
Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decidual Inclusion Closure | Experimental | Procedure: Single-Layered Non-Locked Closure with Decidual InclusionParticipants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture. All other operative steps will be performed according to the standardized study protocol. |
| Decidual Sparing Closure | Experimental | Procedure: Single-Layered Non-Locked Closure with Decidual SparingParticipants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture. All other operative steps will be performed according to the standardized study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton, term pregnancy
- Elective cesarean section before labor onset or membrane rupture
- Maternal age >18 years
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Placenta previa
- Maternal substance abuse or infection
- Suspected placenta accreta
- Diabetes
- one or more prior cesarean section
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 |
|---|---|---|
| Single-Layered Non-Locked Closure with Decidual InclusionDuring the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health. | Procedure or surgery | Decidual Inclusion Closure |
| Single-Layered Non-Locked Closure with Decidual SparingProcedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications. | Procedure or surgery | Decidual Sparing Closure |
Primary outcome
Proportion of participants with a cesarean scar niche measured by ultrasound
Time frame: 6 to 9 months post-operation
Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound. The outcome will be reported as the proportion of participants with a niche in each treatment group.
17 secondary outcomes
Operative time
Time frame: Periprocedural
Need for additional sutures for hemostasis
Time frame: Periprocedural
Length of hospital stay
Time frame: Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
Time frame: Postoperative day 2
Postoperative bleeding
Time frame: Postoperative day 2
Wound infection
Time frame: Postoperative day 2
Postoperative fever
Time frame: Postoperative day 2
Abnormal uterine bleeding
Time frame: 6 to 9 months post-operation
Dysmenorrhea
Time frame: 6 to 9 months post-operation
Chronic pelvic pain
Time frame: 6 to 9 months post-operation
Dyspareunia
Time frame: 6 to 9 months post-operation
Cesarean scar niche length measured by ultrasound in mm
Time frame: 6 to 9 months post-operation
Cesarean scar niche depth measured by ultrasound in mm
Time frame: 6 to 9 months post-operation
Cesarean scar niche width measured by ultrasound in mm
Time frame: 6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
Time frame: 6 to 9 months post-operation
Presence of intrauterine fluid on ultrasound
Time frame: 6 to 9 months post-operation
Residual-to-adjacent myometrial thickness ratio
Time frame: 6 to 9 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared outside the research team because no external data-sharing process has been approved by the ethics committee or institution. Aggregate study results may be shared through publication or presentation.
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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.
Amr S. Hamza, Assoc. Prof. principal investigator
Kantonsspital Baden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Layered Non-Locked Closure with Decidual Inclusion and Single-Layered Non-Locked Closure with Decidual Sparing in people with Isthmocele and Cesarean Scar Diverticula, run by Kantonsspital Baden at 1 site in Switzerland.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr S. Hamza, Assoc. Prof. (+41564863513, amr.hamza@ksb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a cesarean scar niche measured by ultrasound (time frame: 6 to 9 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.