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

Cesarean Scar Niche Clinical Trial

— NICUM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02410395
• Other study ID #: AUH060804
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: March 2023

Study information

• Verified date: May 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: March 2023
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Singleton pregnant

• Intended elective cesarean section

Exclusion Criteria:

• Cervical dilatation of more than 4 cm

• Previous cesarean section

Related Conditions & MeSH terms

• Cesarean Scar Niche

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	Dep. Obstetrics and Gynecology, Regional Hospital of Randers	Randers

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a cesarean scar niche more than 2 mm deep.		6 months
Secondary	Residual myometrial thickness of the cesarean scar (RMT)		6 months
Secondary	Cesarean scar niche depth, width, length, myometrium adjacent to the scar		6 months
Secondary	Post-menstrual spotting		15 months
Secondary	Incidence of cesarean scar pregnancy or spontaneous abortions		72 months
Secondary	Adverse pregnancy outcomes in the following pregnancy	Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence	72 months