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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Cesarean Scar Niche
• Intervention / Treatment: Procedure: Conventional; Procedure: Modified

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Randers, Denmark, 8930
    • Dep. Obstetrics and Gynecology, Regional Hospital of Randers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnant
• Intended elective cesarean section

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional technique; Closure of the uterotomy with a conventional two-layer technique	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.
Experimental: Modified technique; Closure of the uterotomy with a modified two-layer technique	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of a cesarean scar niche more than 2 mm deep.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence	72 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Randers Regional Hospital
• Investigators: Study Chair: Niels Uldbjerg, MD, DMSc, Aarhus University Hospital; Study Chair: Lone Hvidman, MD, PhD, Aarhus University Hospital; Study Chair: Axel Forman, MD, DMSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 2, 2018
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AUH060804