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CS Scar Defect(Niche) How to AvoidPhase 2/3NCT06503627

Incidence of Caesarean Scar Defect in Cases of Cesarean Section With and Without Bladder Flap Dissection

A Phase 2/3 study testing bladder flap dissection in people with CS Scar Defect(Niche) How to Avoid, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anatomically Uterine niche is an iatrogenic pouch-like defect at the site of previous caesarean scar due to defective tissue healing. Radiologically niche should be defined as an indentation at the site of the CS scar with a depth of at least 2 mm. Read more about this study

Who is it for?
Ages 17 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
CS Scar Defect(Niche) How to Avoid
What is being tested?
bladder flap dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteEgypt
Study dates
7 Dec 2022to 20 Feb 2024
Phase
Phase 2/3
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 17 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 1- Patients who will undergo cesarean section for the first time (primi section)

Who cannot join

  • 1- Patient with excessive adhesion that necessitate bladder dissection 2- Previous uterine surgery e.g. myomectomy 3- Patient with comorbidities affecting wound healing e.g. diabetes, autoimmune diseases , immunosuppression 4- Patient in active labour with cervical dilatation > 5cm

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tamer

    Alexandria

Other trials in Egypt

About this study

Anatomically Uterine niche is an iatrogenic pouch-like defect at the site of previous caesarean scar due to defective tissue healing. Radiologically niche should be defined as an indentation at the site of the CS scar with a depth of at least 2 mm. A niche can be subclassified in: (1) simple niche; (2) simple niche with one branch; (3) complex niche (with more than one branch). (1-3) Uterine niche occurs in up to 70% women with previous cesarean of whom 30% are symptomatic. Reported prevalence varies: 24-70% with transvaginal sonography (TVS) and 56-84% with gel/saline instillation sonohysterography (SHG).This may be an underestimation because many women are asymptomatic and also because clinicians may not recognize niche as a cause of symptoms due to unawareness. Prevalence of 45.6% was reported in a prospective observational study (n = 371) where sonohysterography was done six months post-cesarean. Prevalence increases with increasing number of previous cesareans. (1-5) Potential Risk Factors Niche forms due to poor healing of cesarean scar. Risk factors are: (5-8)

  1. Factors Affecting Lower Uterine Segment: Cervical dilatation of > 5 cm, > 5 h duration of labour and advanced fetal station predispose to large niche due to thinner or less vascularized myometrium resulting in inadequate healing(5,6)
  2. Level of Uterine Incision Lower uterine incision towards the cervix results in poor healing, as mucus secreted by cervical glands interferes with myometrial approximation. Mucus accumulation gradually increases the niche size also (5,7) Cesarean section done in advanced labour after cervical effacement and also creation of uterovesical fold of peritoneum influence the level of uterine incision.
  3. Uterine Closure Techniques Single-layer, decidua sparing closure technique predisposes to incomplete closure, compared to single full-thickness closure. A strong myometrial scar with proper anatomical approximation without tissue strangulation minimizes risk of niches (1,8) If muscular edges are thick, they are best approximated by including deeper part in the first layer and the remaining superficial cut edges in the second layer. Non-perpendicular sutures leading to an irregular myometrial closure, locking sutures or very tight second layer leading to ischemic necrosis result in poorly healed scar predisposing to niche formation. Thus, double-layer uterine closure using non-locking sutures is the optimal closure technique that results in thicker residual myometrium and hence potentially lower risk of niches. Suboptimal surgical techniques: Inadequate haemostasis, tissue ischemia, devascularization and excessive tissue manipulation contribute to poor scar healing and adhesions, consequently forming niche.
  4. Adhesions Adhesion formation with abdominal wall pulls the uterine scar towards abdominal wall, exerting counteracting force opposite to the direction of retracting uterine scar tissue and causing impaired wound healing. This mechanism is encountered in non closure of peritoneum and creation of bladder flap that is not sutured. (7)
  5. Retroflexed Uterus Effect of gravity on uterine corpus also increases counteracting forces. Large niches are mostly found with retroflexed uterus. (6,7)
  6. Patient Factors Genetic predisposition contributes to impaired healing, inflammation, or adhesion formation, post-operative infection. (7) Gestational diabetes (odds ratio, 1.73), previous caesarean (OR, 3.14) and advanced body mass index (OR, 1.06) are independent risk factors. Risk increases by 6% for every additional unit increase in body mass index. (8)
Read more

Diagnosis:

Niche can be visualized in non-pregnant state using TVS, SHG, 3-D ultrasound, magnetic resonance imaging or hysteroscopy. An anechoic space at least 2 mm deep in the myometrium at caesarean scar site clinches the diagnosis. Niche Size and Residual Myometrium thickness are measured.

Residual myometrial thickness (RMT) is the vertical distance between uterine serosa and apex of defect. Large niches are defined when RMT is < 50% of adjacent myometrium or ≤ 2.2 mm on TVS. Absent residual myometrium is termed a total defect. (9,10)

Being tested
bladder flap dissection
Keywords
CSD-NICHE-avoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bladder flap dissectionProcedure or surgery

    bladder flap dissection during caesarean section

Study groups in NCT06503627
Study groupRoleWhat they receive
dissection of bladder flap for CSActive comparatorNot described
Receives: Procedure: bladder flap dissection
no dissection of bladder flap for CSNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of CS niche(CS defect)

    ultrasound detection and symptoms for CS NICHE

    Measured: 3 months

Secondary outcomes (1)
  1. AUB (abnormal uterine bleeding) complaint by the patients

    abnormal uterine bleeding in cases of cs niche

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start7 Dec 2022
  3. Primary completion30 Dec 2023
  4. Study completion20 Feb 2024

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 2/3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06503627
Sponsor's protocol ID
CS niche avoidance
Status last verified
Jul 2023
First submitted
10 Jul 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Kulshrestha V, Agarwal N, Kachhawa G. Post-caesarean Niche (Isthmocele) in Uterine Scar: An Update. J Obstet Gynaecol India. 2020 Dec;70(6):440-446. doi: 10.1007/s13224-020-01370-0. Epub 2020 Sep 21.

    PubMed 33417629
  • Vervoort AJ, Uittenbogaard LB, Hehenkamp WJ, Brolmann HA, Mol BW, Huirne JA. Why do niches develop in Caesarean uterine scars? Hypotheses on the aetiology of niche development. Hum Reprod. 2015 Dec;30(12):2695-702. doi: 10.1093/humrep/dev240. Epub 2015 Sep 25.

    PubMed 26409016

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing bladder flap dissection in people with CS Scar Defect(Niche) How to Avoid, run by Alexandria University at 1 site in Egypt.

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: finished, as of the sponsor's last update on 16 Jul 2024. 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 Egypt. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

incidence of CS niche(CS defect) (time frame: 3 months). 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 NCT06503627, 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 16 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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