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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
230
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.
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
Dep. Obstetrics and Gynecology, Regional Hospital of Randers
Randers, Denmark
Presence of a cesarean scar niche more than 2 mm deep.
Time frame: 6 months
Residual myometrial thickness of the cesarean scar (RMT)
Time frame: 6 months
Cesarean scar niche depth, width, length, myometrium adjacent to the scar
Time frame: 6 months
Post-menstrual spotting
Time frame: 15 months
Incidence of cesarean scar pregnancy or spontaneous abortions
Time frame: 72 months
Adverse pregnancy outcomes in the following pregnancy
Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence
Time frame: 72 months
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