Cesarean Scar Niche
Conditions
Brief summary
The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.
Interventions
PROCEDUREConventional
Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer.
PROCEDUREModified
The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably
Sponsors
Randers Regional Hospital
University of Aarhus
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
No
Inclusion criteria
* Singleton pregnant * Intended elective cesarean section
Exclusion criteria
* Cervical dilatation of more than 4 cm * Previous cesarean section
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of a cesarean scar niche more than 2 mm deep. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual myometrial thickness of the cesarean scar (RMT) | 6 months | — |
| Cesarean scar niche depth, width, length, myometrium adjacent to the scar | 6 months | — |
| Post-menstrual spotting | 15 months | — |
| Incidence of cesarean scar pregnancy or spontaneous abortions | 72 months | — |
| Adverse pregnancy outcomes in the following pregnancy | 72 months | Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence |
Countries
Denmark
Outcome results
None listed