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Cesarean Section; DehiscenceNCT06308172

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

A study testing Hysterotomy closure in people with Cesarean Section; Dehiscence and Uterine Bleeding, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Hysterotomy closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
1 Dec 2021to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • coagulopathy
  • autoimmune diseases
  • gestational diabetes
  • anticoagulant therapy
  • immunosuppressive therapy
  • endometriosis
Show all 9Show fewer
  • uterine fibromatosis
  • spontaneous labour
  • connective tissue diseases

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppe Perugino, MD contact

3383030553 ext. +39

giuseppe.perugino@policlinico.mi.it

Italy1 site, 1 recruiting

  • Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano

    Milan, Mi, 20122

    Giuseppe Perugino, MD, 3383030553, giuseppe.perugino@policlinico.mi.it

    Floriana Carbone, MD

    Recruiting

Other trials in Italy

About this study

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

Read the 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.

Being tested
Hysterotomy closure
Medical subject headings
Uterine Hemorrhage, Cicatrix, Uterine Anomalies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hysterotomy closureProcedure or surgery

    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.

Study groups in NCT06308172
Study groupRoleWhat they receive
Single-layerExperimentalPatients who are randomized in this arm undergo a single layer-hysterotomy closure
Receives: Procedure: Hysterotomy closure
Double-layerExperimentalPatients who are randomized in this arm undergo a double layer-hysterotomy closure
Receives: Procedure: Hysterotomy closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intermenstrual bleeding reduction (days)

    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.

    Measured: 6 months

Secondary outcomes (6)

  1. Intra-operatory time

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

    Measured: 6 months

  2. Blood loss

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

    Measured: 6 months

  3. Analgesics

    Evaluate any difference in post-operative use of analgesics

    Measured: 6 months

  4. Post-operatory recovery time

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

    Measured: 6 months

  5. Time to full patient mobilization

    Evaluate any difference in post-operative time to full mobilization

    Measured: 6 months

  6. Isthmocele

    Evaluate any difference in isthmocele incidence between the two groups

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start1 Dec 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308172
Sponsor's protocol ID
CSI/2021
Status last verified
Mar 2023
First submitted
6 Mar 2024
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Hegde CV. The never ending debate single-layer versus double-layer closure of the uterine incision at cesarean section. J Obstet Gynaecol India. 2014 Aug;64(4):239-40. doi: 10.1007/s13224-014-0573-9. Epub 2014 Jul 23. No abstract available.

    PubMed 25136167

  • Qayum K, Kar I, Sofi J, Panneerselvam H. Single- Versus Double-Layer Uterine Closure After Cesarean Section Delivery: A Systematic Review and Meta-Analysis. Cureus. 2021 Sep 30;13(9):e18405. doi: 10.7759/cureus.18405. eCollection 2021 Sep.

    PubMed 34729282

  • Marchand GJ, Masoud A, King A, Ruther S, Brazil G, Ulibarri H, Parise J, Arroyo A, Coriell C, Goetz S, Christensen A, Sainz K. Effect of single- and double-layer cesarean section closure on residual myometrial thickness and isthmocele - a systematic review and meta-analysis. Turk J Obstet Gynecol. 2021 Dec 24;18(4):322-332. doi: 10.4274/tjod.galenos.2021.71173.

    PubMed 34955322

  • Verberkt C, Stegwee SI, Van der Voet LF, Van Baal WM, Kapiteijn K, Geomini PMAJ, Van Eekelen R, de Groot CJM, de Leeuw RA, Huirne JAF; 2Close study group. Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomized controlled trial (2Close study). Am J Obstet Gynecol. 2024 Sep;231(3):346.e1-346.e11. doi: 10.1016/j.ajog.2023.12.032. Epub 2023 Dec 26.

    PubMed 38154502

  • Budny-Winska J, Zimmer-Stelmach A, Pomorski M. Impact of selected risk factors on uterine healing after cesarean section in women with single-layer uterine closure: A prospective study using two- and three-dimensional transvaginal ultrasonography. Adv Clin Exp Med. 2022 Jan;31(1):41-48. doi: 10.17219/acem/142519.

    PubMed 34738347

  • Di Spiezio Sardo A, Saccone G, McCurdy R, Bujold E, Bifulco G, Berghella V. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Nov;50(5):578-583. doi: 10.1002/uog.17401. Epub 2017 Oct 9.

    PubMed 28070914

Questions about this trial

What is this clinical trial studying?

A study testing Hysterotomy closure in people with Cesarean Section; Dehiscence and Uterine Bleeding, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Perugino, MD (3383030553 ext. +39, giuseppe.perugino@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intermenstrual bleeding reduction (days) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308172, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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