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

NCT02410395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-05-15

No results posted yet for this study

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.

Conditions

  • Cesarean Scar Niche

Interventions

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.

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

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Uldbjerg, MD, DMSc · Aarhus University Hospital

  • Lone Hvidman, MD, PhD · Aarhus University Hospital

  • Axel Forman, MD, DMSc · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2018-05-02
Completion
2023-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410395 on ClinicalTrials.gov