Cesarean Incision, Double Layer Closure, Niche Development, Single Layer, Unlocked Sutures
Conditions
Brief summary
This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.
Detailed description
One of the most performed major surgeries worldwide is a cesarean section (CS), and CS rates are rising. These long-term complications are associated with an anatomical defect of the myometrium due to impaired healing of the incision in the uterus, a so-called uterine niche or cesarean scar defect, and with this increased rate of cesarean delivary the development of uterine niche has also increased In 50-70% of patients after cesarean section. The classification of niche was based on the measurement of the depth, base of the isthmocele and on calculation of its triangular area. This allowed to classify the uterine niches after cesarean section according to the size of its area.
Interventions
PROCEDURESingle layer unlocked sutures
Patients underwent uterine scar closure by single layer unlocked sutures.
PROCEDUREDouble layer unlocked sutures
Patients underwent uterine scar closure by double layer unlocked sutures.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Women who undergo first elective cesarean section (CS).
Exclusion criteria
* Women with a previous CS * Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy * previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly * Placenta increta or percreta during the current pregnancy * ≥ Three foetuses during the current pregnancy. * Placenta previa * Twins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the presence of niche | 6 months after the procedure | Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding |
Countries
Egypt
Outcome results
None listed