Uterine Scar Defect
Conditions
Keywords
cesarean, ultrasound, hysterotomy, uterus, suture
Brief summary
This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.
Interventions
PROCEDUREClosure of the hysterotomy at the time of primary cesarean
Sponsors
Laval University
Université de Montréal
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Planned cesarean * Primary cesarean * ≥ 38 gestational weeks
Exclusion criteria
* Previous cesarean * Women \< 18 years old * Multiple gestation * Mullerian anomalies * Active labor * Diabetes * BMI \>35 kg/m2 * Placenta praevia * Chronic systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean myometrium thickness | 6 months after intervention | Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure. |
Secondary
| Measure | Time frame |
|---|---|
| Estimated blood loss | Same day of intervention: day 1 |
| Operative time | Same day of intervention: day 1 |
| Mean number of haemostatic sutures | Same day of intervention: day 1 |
Countries
Canada
Outcome results
None listed