Cesarean Section ComplicationsNCT06324331
Effect of Decidual Sparing in cs Niche Formation
A study testing Decidual sparing and Non decidual sparing in people with Cesarean Section Complications and Cesarean Section Niche, run by Assiut University.
Trial summary
Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Cesarean Section Niche
- What is being tested?
- Decidual sparing and Non decidual sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Dec 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnancy of gestational age ≥ 32wks
Who cannot join
- previous uterine scar
About this study
Official title: The Impact of Decidual al Sparing During Uterine Closure on Post Cesarean Niche Formation
Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment
Read the detailed description
A Cesarean scar defect (CSD) or niche, also termed isthmocele, has been the subject of intensive research over the past 20 years, which resulted in over 3000 publications worldwide. At the beginning of the twentieth century, a cesarean scar described as furrow was noted in hysterectomized uteri of women after a Cesarean delivery (CD). In 2001, Monteagudo et al. described a specific intrauterine defect or niche, using saline infusion sonohysterography (SIS), as a triangular hypoechoic/ anechoic fluid-filled space present in uteri of 40 women with postmenopausal bleeding who had a previous cesarean delivery, reflecting a discontinuity of the myometrium at the site of the uterine incision scar, most likely the result of incomplete healing.The degree of defect, referring to the size of the niche and the thinness of the residual myometrial thickness (RMT) by ultrasound, is often associated with a higher complication rate. The presence of a niche is associated with other dangerous obstetrical complications, such as Cesarean scar pregnancies (CSP), placenta accreta spectrum (PAS), as well as numerous gynecological problems, including intermenstrual spotting, dysmenorrhea, pelvic pain, subfertility, and suboptimal IVF implantation rate.3As the absolute number of CDs increased, their associated complications presented significant challenges for patients, providers, and researchers. Several hypotheses have been advanced to explain niche formation, including oxygen deprivation, poor tissue healing, surgical techniques, and maternal factors.A recent publication described the origin of a post-CD niche following uterine closure. The authors outlined the uterine defect immediately by SIS and, using histopathological studies, demonstrated the presence of the decidua lining the defect, extending, and penetrating the surface of the incision. The inclusion of the endometrium into the uterine closure and lack of myometrial approximation were video recorded.Although these findings have implications for layer-to-layer approximation, the clinical relevance of niche development remains unclear, as its association with intrinsic surgical techniques remains poorly investigated. Possible reasons: Most studies include heterogeneous groups of patients, surgeons, and uterine closure techniques offering no uniform understanding of niche development and size. Reading the history of uterine closure techniques, in 1882, Max Sänger cautioned to avoid the decidua into the uterine closure of the classical cesarean operation, which has become the present-day classical CS8 . The practice of avoiding including the decidua into the uterine wall closure was taught and practiced until the 1970s, gradually losing popularity as newer closure techniques were described.10-12 These more recent developments made no reference to how to handle the endometrium during incision closure. The impact of the endometrium on scar strength and integrity has been studied in animal and human models.A recent retrospective study of 4496 consecutive deliveries was conducted and concluded that there was no abnormal placentation in subsequent pregnancies of 737 women who underwent a CD during the 30-year period when a specific technique termed endometrium-free uterine closure technique (EFCT) was employed16 . This study compares the incidence and size of uterine niches after routine closure technique of the CD incision versus the EFCT using TVUS in their non-pregnant state among women with one prior CD.
- Being tested
- Decidual sparing, Non decidual sparing
- Keywords
- Decidual sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decidual sparingProcedure or surgery
Endometrial free uterine closure technique
Non decidual sparingProcedure or surgery
Routine uterine closure technique including endometrium
| Study group | Role | What they receive |
|---|---|---|
| Non decidual sparing | Experimental | uterine incision repair including suturing of the endometrium Receives: Procedure: Non decidual sparing |
| Decidual sparing | Experimental | uterine incision repair without including the endometrium. Receives: Procedure: Decidual sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of decidual sparing on niche formation
Assessing incidence of niche formation in EFCT vs routine uterine closure of CS by TVUS
Measured: 3-6 months post CS
Secondary outcomes (1)
Impact of uterine closure technique on post CS niche criteria
the size of the niche defect measured by depth, width, length, and RMT above its apex
Measured: 3-6 months post CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Abd Elaziaz Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324331
- Sponsor's protocol ID
- Decidual sparing & CS niche
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Decidual al Sparing During Uterine Closure on Post Cesarean Niche Formation
- ClinicalTrials.gov ID
- NCT06324331
- Acronym / sponsor ID
- Decidual sparing & CS niche
- Keywords
- Decidual sparing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Mar 2024 (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.
Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment
Detailed description
A Cesarean scar defect (CSD) or niche, also termed isthmocele, has been the subject of intensive research over the past 20 years, which resulted in over 3000 publications worldwide. At the beginning of the twentieth century, a cesarean scar described as furrow was noted in hysterectomized uteri of women after a Cesarean delivery (CD). In 2001, Monteagudo et al. described a specific intrauterine defect or niche, using saline infusion sonohysterography (SIS), as a triangular hypoechoic/ anechoic fluid-filled space present in uteri of 40 women with postmenopausal bleeding who had a previous cesarean delivery, reflecting a discontinuity of the myometrium at the site of the uterine incision scar, most likely the result of incomplete healing.The degree of defect, referring to the size of the niche and the thinness of the residual myometrial thickness (RMT) by ultrasound, is often associated with a higher complication rate. The presence of a niche is associated with other dangerous obstetrical complications, such as Cesarean scar pregnancies (CSP), placenta accreta spectrum (PAS), as well as numerous gynecological problems, including intermenstrual spotting, dysmenorrhea, pelvic pain, subfertility, and suboptimal IVF implantation rate.3As the absolute number of CDs increased, their associated complications presented significant challenges for patients, providers, and researchers. Several hypotheses have been advanced to explain niche formation, including oxygen deprivation, poor tissue healing, surgical techniques, and maternal factors.A recent publication described the origin of a post-CD niche following uterine closure. The authors outlined the uterine defect immediately by SIS and, using histopathological studies, demonstrated the presence of the decidua lining the defect, extending, and penetrating the surface of the incision. The inclusion of the endometrium into the uterine closure and lack of myometrial approximation were video recorded.Although these findings have implications for layer-to-layer approximation, the clinical relevance of niche development remains unclear, as its association with intrinsic surgical techniques remains poorly investigated. Possible reasons: Most studies include heterogeneous groups of patients, surgeons, and uterine closure techniques offering no uniform understanding of niche development and size. Reading the history of uterine closure techniques, in 1882, Max Sänger cautioned to avoid the decidua into the uterine closure of the classical cesarean operation, which has become the present-day classical CS8 . The practice of avoiding including the decidua into the uterine wall closure was taught and practiced until the 1970s, gradually losing popularity as newer closure techniques were described.10-12 These more recent developments made no reference to how to handle the endometrium during incision closure. The impact of the endometrium on scar strength and integrity has been studied in animal and human models.A recent retrospective study of 4496 consecutive deliveries was conducted and concluded that there was no abnormal placentation in subsequent pregnancies of 737 women who underwent a CD during the 30-year period when a specific technique termed endometrium-free uterine closure technique (EFCT) was employed16 . This study compares the incidence and size of uterine niches after routine closure technique of the CD incision versus the EFCT using TVUS in their non-pregnant state among women with one prior CD.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non decidual sparing | Experimental | Procedure: Non decidual sparinguterine incision repair including suturing of the endometrium |
| Decidual sparing | Experimental | Procedure: Decidual sparinguterine incision repair without including the endometrium. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnancy of gestational age ≥ 32wks
Key exclusion criteria (1 listed)
- previous uterine scar
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 |
|---|---|---|
| Decidual sparingEndometrial free uterine closure technique | Procedure or surgery | Decidual sparing |
| Non decidual sparingRoutine uterine closure technique including endometrium | Procedure or surgery | Non decidual sparing |
Primary outcome
Impact of decidual sparing on niche formation
Time frame: 3-6 months post CS
Assessing incidence of niche formation in EFCT vs routine uterine closure of CS by TVUS
1 secondary outcome
Impact of uterine closure technique on post CS niche criteria
Time frame: 3-6 months post CS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Decidual sparing and Non decidual sparing in people with Cesarean Section Complications and Cesarean Section Niche, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Impact of decidual sparing on niche formation (time frame: 3-6 months post CS). 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 21 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.