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

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ClinicalTrials.gov Identifier: NCT02410395
Recruitment Status : Active, not recruiting
First Posted : April 7, 2015
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Cesarean Scar Niche Procedure: Conventional Procedure: Modified Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique (NICUM Study)
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 2, 2018
Estimated Study Completion Date : March 2023

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




Primary Outcome Measures :
  1. Presence of a cesarean scar niche more than 2 mm deep. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Residual myometrial thickness of the cesarean scar (RMT) [ Time Frame: 6 months ]
  2. Cesarean scar niche depth, width, length, myometrium adjacent to the scar [ Time Frame: 6 months ]
  3. Post-menstrual spotting [ Time Frame: 15 months ]
  4. Incidence of cesarean scar pregnancy or spontaneous abortions [ Time Frame: 72 months ]
  5. Adverse pregnancy outcomes in the following pregnancy [ Time Frame: 72 months ]
    Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnant
  • Intended elective cesarean section

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410395


Locations
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Denmark
Dep. Obstetrics and Gynecology, Regional Hospital of Randers
Randers, Denmark, 8930
Sponsors and Collaborators
University of Aarhus
Randers Regional Hospital
Investigators
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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
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02410395    
Other Study ID Numbers: AUH060804
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018