NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique
NICUM
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedMay 15, 2018
May 1, 2018
3 years
April 1, 2015
May 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of a cesarean scar niche more than 2 mm deep.
6 months
Secondary Outcomes (5)
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
Study Arms (2)
Conventional technique
ACTIVE COMPARATORClosure of the uterotomy with a conventional two-layer technique
Modified technique
EXPERIMENTALClosure of the uterotomy with a modified two-layer technique
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Singleton pregnant
- Intended elective cesarean section
You may not qualify if:
- Cervical dilatation of more than 4 cm
- Previous cesarean section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Randers Regional Hospitalcollaborator
Study Sites (1)
Dep. Obstetrics and Gynecology, Regional Hospital of Randers
Randers, 8930, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
April 7, 2015
Study Start
May 1, 2015
Primary Completion
May 2, 2018
Study Completion
March 1, 2023
Last Updated
May 15, 2018
Record last verified: 2018-05