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

University of Aarhus1 site in 1 country230 target enrollmentMay 1, 2015

ConditionsCesarean Scar Niche

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cesarean Scar Niche
Sponsor: University of Aarhus
Enrollment: 230
Locations: 1
Primary Endpoint: Presence of a cesarean scar niche more than 2 mm deep.
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2015

End Date

March 2023

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Singleton pregnant
•Intended elective cesarean section

Exclusion Criteria

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

Outcomes

Primary Outcomes

Presence of a cesarean scar niche more than 2 mm deep.

Time Frame: 6 months

Secondary Outcomes

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)