NCT02410395

NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique

NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cesarean Scar Niche

Interventions

Type	Name	Description
PROCEDURE	Conventional	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.
PROCEDURE	Modified	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

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-02
• Completion: 2023-03-01
• First posted: 2015-04-07
• Last updated: 2018-05-15

Locations

1 site across 1 country: Denmark