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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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 groups in NCT06324331
Study groupRoleWhat they receive
Non decidual sparingExperimentaluterine incision repair including suturing of the endometrium
Receives: Procedure: Non decidual sparing
Decidual sparingExperimentaluterine 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.

  1. 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)
  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.

  1. First posted21 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

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)
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

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.

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