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

March 6, 2024 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Mi
      • Milan, Mi, Italy, 20122
        • Recruiting
        • Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
        • Contact:
        • Sub-Investigator:
          • Floriana Carbone, MD
        • Sub-Investigator:
          • Ottavio Cassardo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-layer
Patients who are randomized in this arm undergo a single layer-hysterotomy closure
Procedure: 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.
Experimental: Double-layer
Patients who are randomized in this arm undergo a double layer-hysterotomy closure
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermenstrual bleeding reduction (days)
Time Frame: 6 months
The primary outcome of the study is to evaluate weather there is a reduction of intermenstrual bleeding in the six months after cesarean section among the two groups of patients.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operatory time
Time Frame: 6 months
Evaluate evaluate weather there is a difference in operative time among the two groups of patients
6 months
Blood loss
Time Frame: 6 months
Evaluate any difference in intra-operative blood loss (milliliters of blood)
6 months
Analgesics
Time Frame: 6 months
Evaluate any difference in post-operative use of analgesics
6 months
Post-operatory recovery time
Time Frame: 6 months
Evaluate any difference in post-operative recovery time (days)
6 months
Time to full patient mobilization
Time Frame: 6 months
Evaluate any difference in post-operative time to full mobilization
6 months
Isthmocele
Time Frame: 6 months
Evaluate any difference in isthmocele incidence between the two groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Giuseppe Perugino, MD, Ospedale Policlinico Maggiore Ca' Granda Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSI/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with academic interest in cesarean section outcomes. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party

IPD Sharing Time Frame

Data will be available by may 2025

IPD Sharing Access Criteria

Data will be shared upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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