Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2026-12-01

Brief Summary

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The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups

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Detailed Description

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Cesarean section, the most widely performed surgical procedure globally, has seen a significant increase in rates over the past decades, rising from 12.1% in 2000 to 21% in 2015 for various reasons. A recognized complication of cesarean sections is the formation of a uterine niche, commonly referred to as isthmocele. However, the true incidence of this post-operative complication remains uncertain, with reported figures ranging widely from 7% to 80%. The considerable variability in these estimates is attributed in part to the varying sensitivity of diagnostic tools. Moreover, there is a lack of consensus in the literature regarding the definition of a cesarean niche, particularly concerning the dimensions of the defect.

Recent well-designed randomized controlled trials have investigated the long-term outcomes of single versus double-layer hysterotomy closure during C-sections. These studies found no significant differences in isthmocele incidence or intermenstrual spotting. However, limitations such as the lack of correlation between symptom severity and uterine defect dimensions, the inclusion of women in labor, and relatively short follow-up periods are acknowledged weaknesses, prompting the need for further analysis.

Our objective is to compare the outcomes of single versus double-layer hysterotomy closure in terms of intermenstrual spotting and isthmocele incidence in singleton women undergoing elective C-sections. Crucially, standardizing the surgical suturing technique is essential to mitigate potential misleading outcomes resulting from inter-operator variations.

Conditions

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Cesarean Section; Dehiscence Uterine Bleeding Uterus; Scar Uterus Abnormal Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Patients are recruited and randomly assigned to either the "single-layer" or "double-layer" arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out.

Study Groups

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Single-layer

Patients who are randomized in this arm undergo a single layer-hysterotomy closure

Group Type EXPERIMENTAL

Hysterotomy closure

Intervention Type PROCEDURE

Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.

Double-layer

Patients who are randomized in this arm undergo a double layer-hysterotomy closure

Group Type EXPERIMENTAL

Hysterotomy closure

Intervention Type PROCEDURE

Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.

Interventions

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Hysterotomy closure

Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* nulliparous
* singleton
* age 18-45
* spontaneous pregnancy or autologous assisted fertilization
* gestational age 38-40 weeks
* elective C-section
* informed consent

Exclusion Criteria

* coagulopathy
* autoimmune diseases
* gestational diabetes
* anticoagulant therapy
* immunosuppressive therapy
* endometriosis
* uterine fibromatosis
* spontaneous labour
* connective tissue diseases

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No