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

Not Applicable

• Conditions: Cesarean Scar Niche
• Interventions: Procedure: Conventional; Procedure: Modified

• Registration Number: NCT02410395
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Study Start: 2015-05-01
• Status Verified: 2018-05
• Primary Completion: 2018-05-02
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

• Singleton pregnant
• Intended elective cesarean section

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional technique	Conventional	Closure of the uterotomy with a conventional two-layer technique
Modified technique	Modified	Closure of the uterotomy with a modified two-layer technique

Primary Outcome Measures

Name	Time	Method
Presence of a cesarean scar niche more than 2 mm deep.	6 months

Secondary Outcome Measures

Name	Time	Method
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	Composite of placenta previa, placenta accreta or percreta, uterine rupture or dehiscence

Trial Locations

Locations (1)

Dep. Obstetrics and Gynecology, Regional Hospital of Randers; 🇩🇰 Randers, Denmark