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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

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

Treatments: Procedure: Hysterotomy closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06308172

CSI/2021

Details and patient eligibility

About

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

Full description

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Single-layer

Experimental group

Description:

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

Treatment:

Procedure: Hysterotomy closure

Double-layer

Experimental group

Description:

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

Treatment:

Procedure: Hysterotomy closure