Caesarean Scar Defect Clinical Trial
Official title:
Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar
were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by
various authors.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean
section involving myometrial discontinuity at the site of a previous cesarean section scar.
Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy
at the cesarean section scar, rupture of the uterus during a subsequent pregnancy,
dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications
are likely to be associated with poor uterine scar healing following cesarean sections.
Methods concerning closure of the uterine incision need to be considered with regards to
benefit and potential harm in order to offer the best available surgical care to women
undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most
important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the
effects of two different uterine suturing techniques. their aim was to compare the sparse
closure of the uterine incision to classical one layer closure regarding short , mid and long
term results. In deed, they compared :
- duration of surgery and calculated blood loss during surgery as short term results -
incidence of postoperative defective healing of the uterine incision , thickness of the
ultrasound imaged uterine scar as mid-term results .
- Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of
these patients as long-term results.
This is a secondary analyse of a first randomised trial comparing two caesarean techniques :
- Misgav Ladach with a one layer classic uterine closure.
- French ambulatory Caesarean section with a sparse uterine closure . The first trial is
registred under the reference number : NCT03741907. 100 patients with an indication of
an elective caesarean section were included in this trial : 50 had a one layer classic
uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are
enrolled in groupe 2 .
- For the short term results investigators compared : duration of uterine sutures ,
visually estimated and calculated blood loss
- For the mid term results investigators are shuduling for all partient an
hysterosonography 6 mounths after surgery and then will compare : incidence of
postoperative defective healing of the uterine incision , thickness of the ultrasound
imaged uterine scar as mid-term results .
- For the long term results investigators will interview patients 2 years after surgery in
order to check for Incomplete uterine rupture, morbidly placental adhesion during
subsequent pregnancy .
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