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

University of Aarhus

Status: Unknown

Conditions: Cesarean Scar Niche

Treatments: Procedure: Modified; Procedure: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT02410395

AUH060804

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Singleton pregnant
• Intended elective cesarean section

Exclusion criteria

• Cervical dilatation of more than 4 cm
• Previous cesarean section

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

Conventional technique

Active Comparator group

Description:

Closure of the uterotomy with a conventional two-layer technique

Treatment:

Procedure: Conventional

Modified technique

Experimental group

Description:

Closure of the uterotomy with a modified two-layer technique

Treatment:

Procedure: Modified