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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

NCT04799457

Uterine Niche Closure; Incomplete, Uterus

UNKNOWN NA

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

NCT04766073

Cesarean Section Complications Uterine Bleeding

UNKNOWN NA

Laparoscopic Repair of Cesarean Scar Niche

NCT04307524

Cesarean Section Complications

UNKNOWN PHASE2/PHASE3

UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation

NCT05517018

Uterus; Scar

COMPLETED

Deficient Lower Segment Cesarean Section Scar, Does the Type of Suture Matter?

NCT03649256

2 Arms, Conventional Suture, Barbed Suture

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Scar Niche

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional technique

Closure of the uterotomy with a conventional two-layer technique

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type PROCEDURE

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 technique

Closure of the uterotomy with a modified two-layer technique

Group Type EXPERIMENTAL

Modified

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type PROCEDURE