Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06324331 |
| Other study ID # |
Decidual sparing & CS niche |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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
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.
