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NCT Number: NCT06308172

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

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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Key information

Conditions

Cesarean Section; Dehiscence Cesarean Section Complications Cicatrix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Anomalies Uterine Bleeding Uterine Diseases Uterine Hemorrhage Uterus Abnormal Uterus; Scar

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano

Milan, Mi, 20122, Italy

Location status: Recruiting

Location contact

Floriana Carbone, MD

SUB_INVESTIGATOR

Giuseppe Perugino, MD

CONTACT

[email protected]

3383030553

Ottavio Cassardo, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysterotomy closure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intra-operatory time

    Time frame: 6 months

    Evaluate evaluate weather there is a difference in operative time among the two groups of patients

  2. Blood loss

    Time frame: 6 months

    Evaluate any difference in intra-operative blood loss (milliliters of blood)

  3. Analgesics

    Time frame: 6 months

    Evaluate any difference in post-operative use of analgesics

  4. Post-operatory recovery time

    Time frame: 6 months

    Evaluate any difference in post-operative recovery time (days)

  5. Time to full patient mobilization

    Time frame: 6 months

    Evaluate any difference in post-operative time to full mobilization

  6. Isthmocele

    Time frame: 6 months

    Evaluate any difference in isthmocele incidence between the two groups

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Perugino, MD

CONTACT

[email protected]

3383030553 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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