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Clinical Trials/NCT02410395
NCT02410395UnknownNot Applicable

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

University of Aarhus1 site in 1 country230 target enrollmentStarted: May 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
230
Locations
1
Primary Endpoint
Presence of a cesarean scar niche more than 2 mm deep.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Singleton pregnant
  • •Intended elective cesarean section

Exclusion Criteria

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

Arms & Interventions

Conventional technique

Active Comparator

Closure of the uterotomy with a conventional two-layer technique

Intervention: Conventional (Procedure)

Modified technique

Experimental

Closure of the uterotomy with a modified two-layer technique

Intervention: Modified (Procedure)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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